Trial Outcomes & Findings for A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111 (NCT NCT03507686)
NCT ID: NCT03507686
Last Updated: 2024-02-23
Results Overview
BCVA was assessed for both eyes using the ETDRS visual acuity (VA) chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
COMPLETED
PHASE2
66 participants
Month 12
2024-02-23
Participant Flow
Participants were enrolled at the investigative sites in France, Germany, and the United States from 29 November 2017 to 29 June 2022.
A total of 66 unique male participants with Choroideremia were treated in the study. Of which 60 participants were treated in treatment Period 1 and 50 participants completed Period 1. 50 participants from Period 1 enrolled in Period 2 along with 6 unique participants who were treated in the first eye in a previous study (20150371 \[NCT02553135\], THOR-TUE-01 \[NCT02671539\]). 53 participants completed Period 2.
Participant milestones
| Measure |
Treatment Period 1: BIIB111
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Treatment Period 1(Day 1 up to Month 12)
STARTED
|
60
|
0
|
|
Treatment Period 1(Day 1 up to Month 12)
COMPLETED
|
50
|
0
|
|
Treatment Period 1(Day 1 up to Month 12)
NOT COMPLETED
|
10
|
0
|
|
Treatment Period 2 (Month13 to Month24)
STARTED
|
0
|
56
|
|
Treatment Period 2 (Month13 to Month24)
COMPLETED
|
0
|
53
|
|
Treatment Period 2 (Month13 to Month24)
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Treatment Period 1: BIIB111
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Treatment Period 1(Day 1 up to Month 12)
Serious Adverse Event
|
4
|
0
|
|
Treatment Period 1(Day 1 up to Month 12)
Withdrawal by Subject
|
2
|
0
|
|
Treatment Period 1(Day 1 up to Month 12)
Site Terminated by Sponsor
|
2
|
0
|
|
Treatment Period 1(Day 1 up to Month 12)
Reason not Specified
|
2
|
0
|
|
Treatment Period 2 (Month13 to Month24)
Death
|
0
|
1
|
|
Treatment Period 2 (Month13 to Month24)
Reason not Specified
|
0
|
2
|
Baseline Characteristics
A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111
Baseline characteristics by cohort
| Measure |
All Treated Participants
n=66 Participants
After vitrectomy and retinal detachment in the study eye 1 and study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1 and Period 2 respectively.
|
|---|---|
|
Age, Continuous
|
36.7 Years
STANDARD_DEVIATION 13.57 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
BCVA was assessed for both eyes using the ETDRS visual acuity (VA) chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12
Study Eye 1
|
68.0 letters
Standard Deviation 25.18
|
76.5 letters
Standard Deviation 13.78
|
|
Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12
Study Eye 2
|
82.3 letters
Standard Deviation 8.67
|
81.2 letters
Standard Deviation 10.82
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
IOP, the fluid pressure inside the eye was measured and reported in millimeters mercury (mmHg).
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=52 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12
Study Eye 1
|
13.5 mmHg
Standard Deviation 3.09
|
13.5 mmHg
Standard Deviation 3.12
|
|
Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12
Study Eye 2
|
14.9 mmHg
Standard Deviation 2.50
|
13.5 mmHg
Standard Deviation 3.55
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category at specified timepoint.
Slit lamp examinations of study eyes included examination of Cornea, Conjunctiva, Iris, Lens, and Anterior Segment.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=60 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=56 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Cornea: Study Eye 1: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Cornea: Study Eye 1: Month 12
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Cornea: Study Eye 2: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Cornea: Study Eye 2: Month 12
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Conjunctiva: Study Eye 1: Baseline
|
0 Participants
|
1 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Conjunctiva: Study Eye 1: Month 12
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Conjunctiva: Study Eye 2: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Conjunctiva: Study Eye 2: Month 12
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Iris: Study Eye 1: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Iris: Study Eye 1: Month 12
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Iris: Study Eye 2: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Iris: Study Eye 2: Month 12
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Lens: Study Eye 1: Baseline
|
2 Participants
|
2 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Lens: Study Eye 1: Month 12
|
1 Participants
|
4 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Lens: Study Eye 2: Baseline
|
2 Participants
|
2 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Lens: Study Eye 2: Month 12
|
0 Participants
|
3 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Anterior Segment: Study Eye 1: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Anterior Segment: Study Eye 1: Month 12
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Anterior Segment: Study Eye 2: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Anterior Segment: Study Eye 2: Month 12
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category at specified timepoint.
Dilated Ophthalmoscopy examination of study eyes included examination of Vitreous, Macula, Peripheral retina, Choroid, and Optic nerve.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=60 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=56 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Vitreous: Study Eye 2: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Vitreous: Study Eye 2: Month 12
|
0 Participants
|
1 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Macula: Study Eye 1: Baseline
|
57 Participants
|
54 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Vitreous: Study Eye 1: Baseline
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Vitreous: Study Eye 1: Month 12
|
1 Participants
|
1 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Macula: Study Eye 1: Month 12
|
15 Participants
|
51 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Macula: Study Eye 2: Baseline
|
58 Participants
|
54 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Macula: Study Eye 2: Month 12
|
15 Participants
|
51 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Peripheral Retina: Study Eye 1: Baseline
|
58 Participants
|
54 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Peripheral Retina: Study Eye 1: Month 12
|
15 Participants
|
51 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Peripheral Retina: Study Eye 2: Baseline
|
58 Participants
|
54 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Peripheral Retina: Study Eye 2: Month 12
|
15 Participants
|
51 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Choroid: Study Eye 1: Baseline
|
58 Participants
|
54 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Choroid: Study Eye 1: Month 12
|
15 Participants
|
51 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Choroid: Study Eye 2: Baseline
|
58 Participants
|
54 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Choroid: Study Eye 2: Month 12
|
15 Participants
|
51 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Optic Nerve: Study Eye 1: Baseline
|
5 Participants
|
4 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Optic Nerve: Study Eye 1: Month 12
|
0 Participants
|
3 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Optic Nerve: Study Eye 2: Baseline
|
6 Participants
|
4 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Optic Nerve: Study Eye 2: Month 12
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category of specified parameter.
The following lens opacity grades are reported for categories 1-4: Nuclear Opalescence grade, Nuclear Color grade, Cortical Cataract grade, and Posterior Cataract grade. Opacification severity is graded on a decimal scale, scores can range from 0.1 (no opacity) to 6.9 (maximum opacity) for the Nuclear Opalescence and Nuclear Color grades; and scores can range from 0.1 (lens clear) to 5.9 (lens unclear) for the Cortical and Posterior Cataract grades. Category 1 includes values 1, 1.0 and 0.x, Category 2 includes values 2, 2.0 and 1.x, Category 3 includes values 3, 3.0 and 2.x, and Category 4 includes values 4, 4.0, 3.x and any values above 4. For each opacification type the higher grading scores indicate greater severity.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 1: Study Eye 1
|
13 Participants
|
38 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 2: Study Eye 1
|
1 Participants
|
8 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 3: Study Eye 2
|
0 Participants
|
2 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 1: Study Eye 1
|
14 Participants
|
41 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 1: Study Eye 1
|
13 Participants
|
43 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 2: Study Eye 1
|
1 Participants
|
5 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 1: Study Eye 2
|
14 Participants
|
44 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 3: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 4: Study Eye 1
|
1 Participants
|
1 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 3: Study Eye 1
|
0 Participants
|
4 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 4: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 1: Study Eye 2
|
14 Participants
|
38 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 2: Study Eye 2
|
1 Participants
|
10 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Opalescence Grade: Category 4: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 2: Study Eye 1
|
0 Participants
|
5 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 3: Study Eye 1
|
0 Participants
|
4 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 4: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 1: Study Eye 2
|
15 Participants
|
41 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 2: Study Eye 2
|
0 Participants
|
7 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 3: Study Eye 2
|
0 Participants
|
2 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Nuclear Color Grade: Category 4: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 3: Study Eye 1
|
0 Participants
|
2 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 4: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 2: Study Eye 2
|
1 Participants
|
6 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 3: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Cortical Cataract Grade: Category 4: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 1: Study Eye 1
|
13 Participants
|
40 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 2: Study Eye 1
|
0 Participants
|
6 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 3: Study Eye 1
|
0 Participants
|
3 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 1: Study Eye 2
|
15 Participants
|
44 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 2: Study Eye 2
|
0 Participants
|
6 Participants
|
|
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
Posterior Cataract Grade: Category 4: Study Eye 2
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
SD-OCT was used to assess change in foveal subfield thickness. The measurements were taken after dilation of the participant's pupil.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12
Study Eye 1
|
290.7 microns (µ)
Standard Deviation 69.94
|
258.0 microns (µ)
Standard Deviation 58.20
|
|
Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12
Study Eye 2
|
283.8 microns (µ)
Standard Deviation 46.65
|
270.9 microns (µ)
Standard Deviation 51.66
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in total macular volume. The measurements were taken after dilation of the participant's pupil.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Total Macular Volume at Month 12
Study Eye 1
|
6.770 cubic millimeters (mm^3)
Standard Deviation 1.1384
|
6.638 cubic millimeters (mm^3)
Standard Deviation 1.0934
|
|
SD-OCT: Total Macular Volume at Month 12
Study Eye 2
|
6.903 cubic millimeters (mm^3)
Standard Deviation 1.0875
|
6.741 cubic millimeters (mm^3)
Standard Deviation 1.1616
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in central horizontal ellipsoid width. The measurements were taken after dilation of the participant's pupil.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=14 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=47 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Central Horizontal Ellipsoid Width at Month 12
Study Eye 1
|
2346.0 microns (μ)
Standard Deviation 1511.67
|
1951.2 microns (μ)
Standard Deviation 1223.26
|
|
SD-OCT: Central Horizontal Ellipsoid Width at Month 12
Study Eye 2
|
2230.2 microns (μ)
Standard Deviation 1122.89
|
1950.1 microns (μ)
Standard Deviation 1188.74
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in central ellipsoid area. The measurements were taken after dilation of the participant's pupil.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=8 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=28 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Central Ellipsoid Area at Month 12
Study Eye 1
|
3.213 square millimeters (mm^2)
Standard Deviation 2.1098
|
2.971 square millimeters (mm^2)
Standard Deviation 1.7374
|
|
SD-OCT: Central Ellipsoid Area at Month 12
Study Eye 2
|
4.404 square millimeters (mm^2)
Standard Deviation 2.2848
|
3.810 square millimeters (mm^2)
Standard Deviation 2.5563
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in square root of central ellipsoid area. The measurements were taken after dilation of the participant's pupil.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=8 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=28 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Square Root of Central Ellipsoid Area at Month 12
Study Eye 1
|
1.6980 mm
Standard Deviation 0.62031
|
1.6346 mm
Standard Deviation 0.55842
|
|
SD-OCT: Square Root of Central Ellipsoid Area at Month 12
Study Eye 2
|
2.0331 mm
Standard Deviation 0.55575
|
1.8468 mm
Standard Deviation 0.64385
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
SD-OCT was used to assess change in choroidal thickness. The measurements were taken after dilation of the participant's pupil.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=52 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Choroidal Thickness at Foveal Center at Month 12
Study Eye 1
|
185.5 microns (μ)
Standard Deviation 81.72
|
174.2 microns (μ)
Standard Deviation 85.33
|
|
SD-OCT: Choroidal Thickness at Foveal Center at Month 12
Study Eye 2
|
207.6 microns (μ)
Standard Deviation 85.89
|
190.2 microns (μ)
Standard Deviation 87.40
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified parameter.
Fundus AF was used to assess the total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12
Study Eye 1
|
7.130 mm^2
Standard Deviation 6.2326
|
8.682 mm^2
Standard Deviation 9.8972
|
|
Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12
Study Eye 2
|
8.157 mm^2
Standard Deviation 7.4969
|
9.682 mm^2
Standard Deviation 11.0688
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Fundus AF was used to assess the square root of total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper AF compared with the background areas of surrounding atrophy.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
AF: Mean Square Root of Total Area of Preserved AF at Month 12
Study Eye 1
|
2.4358 mm
Standard Deviation 1.13836
|
2.6149 mm
Standard Deviation 1.37197
|
|
AF: Mean Square Root of Total Area of Preserved AF at Month 12
Study Eye 2
|
2.6214 mm
Standard Deviation 1.17348
|
2.7550 mm
Standard Deviation 1.46149
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Fundus AF was used to assess the distance from foveal center to nearest border of preserved AF.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12
Study Eye 1
|
423.133 mm
Standard Deviation 559.1529
|
370.245 mm
Standard Deviation 733.1618
|
|
AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12
Study Eye 2
|
539.600 mm
Standard Deviation 602.6063
|
525.212 mm
Standard Deviation 688.7141
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Number of participants with RPE hyperplasia are reported for severity grades: mild, moderate, severe.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=49 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity
Severe: Study Eye 1
|
0 Participants
|
2 Participants
|
|
Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity
Severe: Study Eye 2
|
0 Participants
|
2 Participants
|
|
Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity
Mild: Study Eye 1
|
7 Participants
|
26 Participants
|
|
Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity
Mild: Study Eye 2
|
9 Participants
|
23 Participants
|
|
Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity
Moderate: Study Eye 1
|
8 Participants
|
21 Participants
|
|
Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity
Moderate: Study Eye 2
|
6 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Number of participants with retinal arteriolar narrowing are reported for severity grades: mild, moderate, severe.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity
Mild: Study Eye 1
|
13 Participants
|
37 Participants
|
|
Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity
Mild: Study Eye 2
|
12 Participants
|
36 Participants
|
|
Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity
Moderate: Study Eye 1
|
1 Participants
|
10 Participants
|
|
Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity
Moderate: Study Eye 2
|
2 Participants
|
10 Participants
|
|
Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity
Severe: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity
Severe: Study Eye 2
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Number of participants with retinal vessel sheathing are reported for severity grades: mild, moderate, severe.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=49 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity
Mild: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity
Mild: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity
Moderate: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity
Moderate: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity
Severe: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity
Severe: Study Eye 2
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Number of participants with optic atrophy/pallor are reported for severity grades: mild, moderate, severe.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity
Moderate: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity
Moderate: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity
Severe: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity
Severe: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity
Mild: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity
Mild: Study Eye 2
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Number of participants with optic disc swelling are reported for severity grades: mild, moderate, severe.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity
Mild: Study Eye 1
|
0 Participants
|
1 Participants
|
|
Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity
Mild: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity
Moderate: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity
Moderate: Study Eye 2
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity
Severe: Study Eye 1
|
0 Participants
|
0 Participants
|
|
Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity
Severe: Study Eye 2
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess retinal mean sensitivity within the macula. Retinal mean sensitivity to light was measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers (decibels) indicate higher retinal sensitivity.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Retinal Mean Sensitivity at Month 12
Study Eye 1
|
4.05 decibels (dB)
Standard Deviation 4.565
|
5.93 decibels (dB)
Standard Deviation 6.991
|
|
Microperimetry: Retinal Mean Sensitivity at Month 12
Study Eye 2
|
5.41 decibels (dB)
Standard Deviation 5.239
|
6.37 decibels (dB)
Standard Deviation 6.720
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess bivariate contour ellipse area 63%.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12
Study Eye 1
|
7.91 square degrees (deg^2)
Standard Deviation 13.287
|
2.09 square degrees (deg^2)
Standard Deviation 4.701
|
|
Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12
Study Eye 2
|
1.45 square degrees (deg^2)
Standard Deviation 1.874
|
1.92 square degrees (deg^2)
Standard Deviation 5.510
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess bivariate contour ellipse area 95%.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12
Study Eye 1
|
23.69 deg^2
Standard Deviation 39.857
|
6.27 deg^2
Standard Deviation 14.106
|
|
Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12
Study Eye 2
|
4.35 deg^2
Standard Deviation 5.624
|
5.76 deg^2
Standard Deviation 16.518
|
PRIMARY outcome
Timeframe: Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess fixation losses (in percentage) which samples the optic nerve blind spot for positive responses.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=5 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=23 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Fixation Losses (in Percentage) at Month 12
Study Eye 1
|
9.0 percentage (%)
Standard Deviation 12.45
|
2.2 percentage (%)
Standard Deviation 7.20
|
|
Microperimetry: Fixation Losses (in Percentage) at Month 12
Study Eye 2
|
4.0 percentage (%)
Standard Deviation 8.94
|
5.0 percentage (%)
Standard Deviation 9.17
|
PRIMARY outcome
Timeframe: Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug/surgical procedure, whether or not related to the investigational product or with the surgical procedure. TEAEs are defined as AEs starting on or after the day of the first surgery.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=60 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=56 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
|
100 percentage of participants
|
96.4 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, at Month 3Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified parameter.
Tears (for both eyes- oculus dexter \[OD\] and oculus sinister \[OS\]), blood, urine and saliva samples were collected and tested using an appropriate assay for evidence of vector shedding. Participants with positive result for vector shredding post treatment are reported.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=48 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=56 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Number of Participants With Vector Shedding Post-treatment at Month 3
Tears OD
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vector Shedding Post-treatment at Month 3
Tears OS
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vector Shedding Post-treatment at Month 3
Blood
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vector Shedding Post-treatment at Month 3
Saliva
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vector Shedding Post-treatment at Month 3
Urine
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: The immunogenicity analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2 with baseline sample and at least one post-surgery sample evaluable for immunogenicity.
Participants with antibodies to the REP-1 transgenic product are reported.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=60 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=56 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Number of Participants With Anti-drug Antibodies Post-treatment at Month 12
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint.
Change from baseline in Systolic and diastolic blood pressures (BP) (millimeters of mercury \[mmHg\]) were reported.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=60 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=22 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Vital Signs: Change From Baseline in Blood Pressure at Month 12
Systolic BP: Baseline
|
122.3 mmHg
Standard Deviation 14.73
|
125.4 mmHg
Standard Deviation 11.52
|
|
Vital Signs: Change From Baseline in Blood Pressure at Month 12
Systolic BP: Change at Month 12
|
-7.2 mmHg
Standard Deviation 16.12
|
-2.0 mmHg
Standard Deviation 10.65
|
|
Vital Signs: Change From Baseline in Blood Pressure at Month 12
Diastolic BP: Baseline
|
78.3 mmHg
Standard Deviation 9.56
|
80.5 mmHg
Standard Deviation 6.91
|
|
Vital Signs: Change From Baseline in Blood Pressure at Month 12
Diastolic BP: Change at Month 12
|
-1.0 mmHg
Standard Deviation 11.29
|
-1.9 mmHg
Standard Deviation 9.60
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint.
Change from baseline in pulse rate (beats per minute) were reported.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=60 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=22 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Vital Signs: Change From Baseline in Pulse Rate at Month 12
Baseline
|
69.8 beats per minute
Standard Deviation 13.31
|
71.5 beats per minute
Standard Deviation 10.91
|
|
Vital Signs: Change From Baseline in Pulse Rate at Month 12
Change at Month 12
|
6.7 beats per minute
Standard Deviation 16.41
|
0.9 beats per minute
Standard Deviation 10.46
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
BCVA was assessed for both eyes using the ETDRS VA chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Change From Baseline in BCVA as Measured by the ETDRS Chart
Change at Month 12: Study Eye 1
|
-8.6 letters
Standard Deviation 24.55
|
-1.3 letters
Standard Deviation 7.77
|
|
Change From Baseline in BCVA as Measured by the ETDRS Chart
Change at Month 12: Study Eye 2
|
2.2 letters
Standard Deviation 2.93
|
-2.2 letters
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Fundus AF was used to assess change in total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy. Here negative values indicate decline in total area of preserved autofluoroscence.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12
Change at Month 12: Study Eye 1
|
-1.158 mm^2
Standard Deviation 1.3362
|
-1.502 mm^2
Standard Deviation 1.9315
|
|
AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12
Change at Month 12: Study Eye 2
|
-0.772 mm^2
Standard Deviation 0.5381
|
-1.313 mm^2
Standard Deviation 1.9967
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Fundus AF was used to assess change in square root of total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper AF compared with the background areas of surrounding atrophy. Here negative values indicate decline in total area of preserved autofluoroscence.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=50 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12
Change at Month 12: Study Eye 1
|
-0.1981 mm
Standard Deviation 0.13033
|
-0.2197 mm
Standard Deviation 0.18111
|
|
AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12
Change at Month 12: Study Eye 2
|
-0.1345 mm
Standard Deviation 0.04362
|
-0.1736 mm
Standard Deviation 0.16090
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
Fundus Autofluoroscence was used to assess change in distance from foveal center to nearest border of preserved autofluoroscence. Here negative values indicate decline in total area of preserved autofluoroscence.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12
Change at Month 12: Study Eye 1
|
-160.000 mm
Standard Deviation 197.9094
|
-94.321 mm
Standard Deviation 106.4964
|
|
AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12
Change at Month 12: Study Eye 2
|
-76.000 mm
Standard Deviation 71.9107
|
-80.596 mm
Standard Deviation 135.5793
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
SD-OCT was used to assess change in foveal subfield thickness. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in foveal subfield thickness.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12
Change at Month 12: Study Eye 1
|
1.7 microns (μ)
Standard Deviation 53.08
|
-2.9 microns (μ)
Standard Deviation 12.02
|
|
SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12
Change at Month 12: Study Eye 2
|
-3.5 microns (μ)
Standard Deviation 7.40
|
-5.7 microns (μ)
Standard Deviation 23.96
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in total macular volume. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in total macular volume.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Change From Baseline in Total Macular Volume at Month 12
Change at Month 12: Study Eye 1
|
-0.201 mm^3
Standard Deviation 0.2275
|
-0.188 mm^3
Standard Deviation 0.1400
|
|
SD-OCT: Change From Baseline in Total Macular Volume at Month 12
Change at Month 12: Study Eye 2
|
-0.093 mm^3
Standard Deviation 0.1344
|
-0.233 mm^3
Standard Deviation 0.3969
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in central horizontal ellipsoid width. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in central horizontal ellipsoid width.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=14 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=44 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12
Change at Month 12: Study Eye 1
|
-156.8 microns (μ)
Standard Deviation 185.66
|
-161.5 microns (μ)
Standard Deviation 299.00
|
|
SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12
Change at Month 12: Study Eye 2
|
-217.5 microns (μ)
Standard Deviation 388.56
|
-150.4 microns (μ)
Standard Deviation 360.87
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in central ellipsoid area. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in central ellipsoid area.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=7 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=27 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12
Change at Month 12: Study Eye 1
|
-0.408 mm^2
Standard Deviation 0.2184
|
-0.452 mm^2
Standard Deviation 0.2776
|
|
SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12
Change at Month 12: Study Eye 2
|
-0.466 mm^2
Standard Deviation 0.3543
|
-0.369 mm^2
Standard Deviation 0.3425
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
SD-OCT was used to assess change in square root of central ellipsoid area. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in square root of central ellipsoid area.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=7 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=27 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12
Change at Month 12: Study Eye 1
|
-0.1348 mm
Standard Deviation 0.08110
|
-0.1345 mm
Standard Deviation 0.06117
|
|
SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12
Change at Month 12: Study Eye 2
|
-0.1121 mm
Standard Deviation 0.08193
|
-0.0944 mm
Standard Deviation 0.09347
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
SD-OCT was used to assess change in choroidal thickness. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in choroidal thickness.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=52 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12
Change at Month 12: Study Eye 1
|
-12.9 microns (μ)
Standard Deviation 35.57
|
-13.7 microns (μ)
Standard Deviation 30.73
|
|
SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12
Change at Month 12: Study Eye 2
|
-9.8 microns (μ)
Standard Deviation 23.73
|
2.9 microns (μ)
Standard Deviation 23.62
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess change in retinal mean sensitivity within the macula. Retinal mean sensitivity to light was measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers (decibels) indicate higher retinal sensitivity. A negative change from baseline indicates decline in retinal sensitivity.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12
Change at Month 12: Study Eye 1
|
-0.79 dB
Standard Deviation 1.160
|
-0.38 dB
Standard Deviation 1.931
|
|
Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12
Change at Month 12: Study Eye 2
|
0.15 dB
Standard Deviation 0.725
|
-0.73 dB
Standard Deviation 1.435
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess change in bivariate contour ellipse area 63%. A negative change from baseline indicates decline in bivariate contour ellipse area 63%.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12
Change at Month 12: Study Eye 1
|
4.42 deg^2
Standard Deviation 14.383
|
-0.22 deg^2
Standard Deviation 6.733
|
|
Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12
Change at Month 12: Study Eye 2
|
-0.02 deg^2
Standard Deviation 1.296
|
0.63 deg^2
Standard Deviation 5.681
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess change in bivariate contour ellipse area 95%. A negative change from baseline indicates decline in bivariate contour ellipse area 95%.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=15 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=53 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12
Change at Month 12: Study Eye 1
|
13.23 deg^2
Standard Deviation 43.125
|
-0.66 deg^2
Standard Deviation 20.204
|
|
Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12
Change at Month 12: Study Eye 2
|
-0.09 deg^2
Standard Deviation 3.866
|
1.90 deg^2
Standard Deviation 17.006
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Microperimetry was conducted to assess change in fixation losses (in percentage) which samples the optic nerve blind spot for positive responses. A negative change from baseline indicates decline in fixation losses.
Outcome measures
| Measure |
Treatment Period 1: BIIB111
n=4 Participants
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=14 Participants
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12
Change at Month 12: Study Eye 1
|
5.3 percentage
Standard Deviation 13.60
|
-4.5 percentage
Standard Deviation 11.72
|
|
Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12
Change at Month 12: Study Eye 2
|
-6.3 percentage
Standard Deviation 12.50
|
2.8 percentage
Standard Deviation 7.40
|
Adverse Events
Treatment Period 1: BIIB111
Treatment Period 2: BIIB111
Serious adverse events
| Measure |
Treatment Period 1: BIIB111
n=60 participants at risk
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=56 participants at risk
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
16.7%
10/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
10.7%
6/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Noninfective retinitis
|
3.3%
2/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
0.00%
0/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Blindness unilateral
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
0.00%
0/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Choroidal neovascularisation
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
0.00%
0/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Eye inflammation
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
0.00%
0/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Macular hole
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
1.8%
1/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
1.8%
1/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Retinal detachment
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
0.00%
0/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Tractional retinal detachment
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
1.8%
1/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Vitreous haemorrhage
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
0.00%
0/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
1.8%
1/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
1.8%
1/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
1.8%
1/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
1.8%
1/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
0.00%
0/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
Other adverse events
| Measure |
Treatment Period 1: BIIB111
n=60 participants at risk
After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1.
|
Treatment Period 2: BIIB111
n=56 participants at risk
After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2.
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
63.3%
38/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
64.3%
36/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Anterior chamber cell
|
48.3%
29/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
57.1%
32/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Eye pain
|
15.0%
9/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
17.9%
10/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Foreign body sensation in eyes
|
18.3%
11/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
17.9%
10/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
18.3%
11/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
10.7%
6/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Eye irritation
|
13.3%
8/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
16.1%
9/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Vitreal cells
|
11.7%
7/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
7.1%
4/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Vitritis
|
11.7%
7/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
14.3%
8/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Ocular discomfort
|
5.0%
3/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
12.5%
7/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Visual impairment
|
15.0%
9/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
7.1%
4/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Conjunctival oedema
|
10.0%
6/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
5.4%
3/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Vision blurred
|
6.7%
4/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
10.7%
6/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Anterior chamber flare
|
8.3%
5/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
7.1%
4/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Dry eye
|
3.3%
2/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
10.7%
6/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Metamorphopsia
|
3.3%
2/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
8.9%
5/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Photopsia
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
10.7%
6/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Visual acuity reduced
|
6.7%
4/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
5.4%
3/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Cataract
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
7.1%
4/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Cystoid macular oedema
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
7.1%
4/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Eye pruritus
|
5.0%
3/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
5.4%
3/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Subretinal fluid
|
5.0%
3/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
3.6%
2/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Vitreous floaters
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
7.1%
4/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Cataract subcapsular
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
5.4%
3/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Eyelid ptosis
|
1.7%
1/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
7.1%
4/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Eye disorders
Ocular hypertension
|
5.0%
3/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
3.6%
2/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
8/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
10.7%
6/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Investigations
Intraocular pressure increased
|
10.0%
6/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
14.3%
8/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Nervous system disorders
Headache
|
11.7%
7/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
12.5%
7/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/60 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
5.4%
3/56 • Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally, the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor's Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of the Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER