Trial Outcomes & Findings for A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD) (NCT NCT03539549)
NCT ID: NCT03539549
Last Updated: 2020-08-03
Results Overview
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. 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. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
COMPLETED
PHASE2
124 participants
Baseline (Day 1) to Week 28
2020-08-03
Participant Flow
A total of 124 participants were enrolled in the study. Out of 124, one participant was not treated with study drug and was subsequently discontinued from the study. The participant was not included in the Safety Population or analyses.
Participant milestones
| Measure |
Abicipar Pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Overall Study
STARTED
|
123
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Abicipar Pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Progressive Disease
|
1
|
|
Overall Study
Reason not Specified
|
1
|
Baseline Characteristics
Number analyzed is the number of participants with BCVA data available at baseline.
Baseline characteristics by cohort
| Measure |
Abicipar Pegol 2 mg
n=123 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Age, Continuous
|
78.3 years
STANDARD_DEVIATION 8.21 • n=123 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=123 Participants
|
|
Best Corrected Visual Acuity (BCVA)
|
62.0 letters
STANDARD_DEVIATION 12.19 • n=122 Participants • Number analyzed is the number of participants with BCVA data available at baseline.
|
|
Central Retinal Thickness (CRT)
|
353.1 microns
STANDARD_DEVIATION 94.05 • n=122 Participants • Number analyzed is the number of participants with CRT data available at Baseline.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 28Population: Safety Population included all participants who received at least 1 administration of study treatment.
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. 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. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=123 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Percentage of Participants With Stable Vision
|
97.6 percentage of participants
Interval 94.2 to 99.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 28Population: Safety Population included all participants who received at least 1 administration of study treatment. Number analyzed is the number of participants with data available at the given time point.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=123 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
|
-82.5 microns
Standard Deviation 102.13
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 28Population: Safety Population included all participants who received at least 1 administration of study treatment. Overall number of participants analyzed are the participants with data available for analyses.
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=106 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 28Population: Safety Population included all participants who received at least 1 administration of study treatment. Overall number of participants analyzed are the participants with data available for analyses.
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=106 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Change Form Baseline in BCVA in the Study Eye
|
3.6 letters
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 28Population: Safety Population included all participants who received at least 1 administration of study treatment.
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=123 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye
|
9.8 percentage of participants
Interval 5.2 to 16.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 28Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 28Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 28Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 28Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 28Outcome measures
Outcome data not reported
Adverse Events
Abicipar Pegol 2 mg
Serious adverse events
| Measure |
Abicipar Pegol 2 mg
n=123 participants at risk
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
2/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Iritis
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Retinal haemorrhage
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Vitritis
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.6%
2/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Dysarthria
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
|
Vascular disorders
Hypertension
|
0.81%
1/123 • From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER