Trial Outcomes & Findings for Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery (NCT NCT01048593)
NCT ID: NCT01048593
Last Updated: 2018-12-04
Results Overview
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Day 8 post treatment
Results posted on
2018-12-04
Participant Flow
Participant milestones
| Measure |
Dose 1
114ug dose group
|
Dose 2
513ug dose group
|
Dose 3
684ug dose group
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
3
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery
Baseline characteristics by cohort
| Measure |
Dose 1
n=3 Participants
114ug dose group
|
Dose 2
n=2 Participants
513ug dose group
|
Dose 3
n=1 Participants
684ug dose group
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Age, Customized
Between 18 and 65 years
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Sex/Gender, Customized
Female
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Sex/Gender, Customized
Unknown
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
6 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 8 post treatmentEfficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
Outcome measures
| Measure |
Dose 1
n=3 Participants
114ug
IBI-10090: Single intraocular injection
|
Dose 2
n=2 Participants
513ug
IBI-10090: Single intraocular injection
|
Dose 3
n=1 Participants
684ug
IBI-10090: Single intraocular injection
|
|---|---|---|---|
|
Clearance of Anterior Chamber Cells
Baseline · Grade 1 (1-5 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clearance of Anterior Chamber Cells
Baseline · Grade 2 (6-15 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clearance of Anterior Chamber Cells
POD 8 · Grade 3 (16-30 cells)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Clearance of Anterior Chamber Cells
Baseline · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Clearance of Anterior Chamber Cells
Baseline · Grade 3 (16-30 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clearance of Anterior Chamber Cells
Baseline · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clearance of Anterior Chamber Cells
POD 8 · Grade 0 (absent)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clearance of Anterior Chamber Cells
POD 8 · Grade 1 (1-5 cells)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clearance of Anterior Chamber Cells
POD 8 · Grade 2 (6-15 cells)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Clearance of Anterior Chamber Cells
POD 8 · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90 post-treatmentEfficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Outcome measures
| Measure |
Dose 1
n=3 Participants
114ug
IBI-10090: Single intraocular injection
|
Dose 2
n=2 Participants
513ug
IBI-10090: Single intraocular injection
|
Dose 3
n=1 Participants
684ug
IBI-10090: Single intraocular injection
|
|---|---|---|---|
|
Anterior Chamber Flare (ACF) Grade
Baseline · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Anterior Chamber Flare (ACF) Grade
Baseline · Grade 1 (trace)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
Baseline · Grade 4 (strong intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 90 · Grade 1 (trace)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 90 · Grade 2 (mild intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
Baseline · Grade 2 (mild intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
Baseline · Grade 3 (moderate Intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 1 · Grade 0 (absent)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 1 · Grade 1 (trace)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 1 · Grade 2 (mild intensity)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 1 · Grade 3 (moderate Intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 1 · Grade 4 (strong intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 3 · Grade 0 (absent)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 3 · Grade 1 (trace)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 3 · Grade 2 (mild intensity)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 3 · Grade 3 (moderate Intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 3 · Grade 4 (strong intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 8 · Grade 0 (absent)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 8 · Grade 1 (trace)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 8 · Grade 2 (mild intensity)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 8 · Grade 3 (moderate Intensity)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 8 · Grade 4 (strong intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 15 · Grade 0 (absent)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 15 · Grade 1 (trace)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 15 · Grade 2 (mild intensity)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 15 · Grade 3 (moderate Intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 15 · Grade 4 (strong intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 30 · Grade 0 (absent)
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 30 · Grade 1 (trace)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 30 · Grade 2 (mild intensity)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 30 · Grade 3 (moderate Intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 30 · Grade 4 (strong intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 90 · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 90 · Grade 3 (moderate Intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Flare (ACF) Grade
POD 90 · Grade 4 (strong intensity)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90 post-treatmentConjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Outcome measures
| Measure |
Dose 1
n=3 Participants
114ug
IBI-10090: Single intraocular injection
|
Dose 2
n=2 Participants
513ug
IBI-10090: Single intraocular injection
|
Dose 3
n=1 Participants
684ug
IBI-10090: Single intraocular injection
|
|---|---|---|---|
|
Conjunctival Erythema Grade
POD 1 · Grade 3 (bright red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 3 · Grade 0 (no erythema)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Conjunctival Erythema Grade
POD 3 · Grade 1 (pale reddish bulbar)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 3 · Grade 2 (red bulbar)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 30 · Grade 0 (no erythema)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Conjunctival Erythema Grade
POD 90 · Grade 0 (no erythema)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Conjunctival Erythema Grade
POD 90 · Grade 1 (pale reddish bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 90 · Grade 2 (red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 90 · Grade 3 (bright red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 15 · Grade 2 (red bulbar)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
Baseline · Grade 0 (no erythema)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Conjunctival Erythema Grade
Baseline · Grade 1 (pale reddish bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
Baseline · Grade 2 (red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
Baseline · Grade 3 (bright red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 1 · Grade 0 (no erythema)
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Conjunctival Erythema Grade
POD 1 · Grade 1 (pale reddish bulbar)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 1 · Grade 2 (red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 3 · Grade 3 (bright red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 8 · Grade 0 (no erythema)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Conjunctival Erythema Grade
POD 8 · Grade 1 (pale reddish bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 8 · Grade 2 (red bulbar)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 8 · Grade 3 (bright red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 15 · Grade 0 (no erythema)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Conjunctival Erythema Grade
POD 15 · Grade 1 (pale reddish bulbar)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 15 · Grade 3 (bright red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 30 · Grade 1 (pale reddish bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 30 · Grade 2 (red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Conjunctival Erythema Grade
POD 30 · Grade 3 (bright red bulbar)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90 post-treatmentCornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Outcome measures
| Measure |
Dose 1
n=3 Participants
114ug
IBI-10090: Single intraocular injection
|
Dose 2
n=2 Participants
513ug
IBI-10090: Single intraocular injection
|
Dose 3
n=1 Participants
684ug
IBI-10090: Single intraocular injection
|
|---|---|---|---|
|
Corneal Edema Grade
Baseline · Grade 3 (severe edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 1 · Grade 0 (absent)
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 3 · Grade 3 (severe edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 8 · Grade 0 (absent)
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Corneal Edema Grade
POD 15 · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Corneal Edema Grade
POD 15 · Grade 1 (mild edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 30 · Grade 3 (severe edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 90 · Grade 1 (mild edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 90 · Grade 2 (moderate edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 90 · Grade 3 (severe edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
Baseline · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Corneal Edema Grade
Baseline · Grade 1 (mild edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
Baseline · Grade 2 (moderate edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 1 · Grade 1 (mild edema)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Corneal Edema Grade
POD 1 · Grade 2 (moderate edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 1 · Grade 3 (severe edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 3 · Grade 0 (absent)
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Corneal Edema Grade
POD 3 · Grade 1 (mild edema)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 3 · Grade 2 (moderate edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 8 · Grade 1 (mild edema)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 8 · Grade 2 (moderate edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 8 · Grade 3 (severe edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 15 · Grade 2 (moderate edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 15 · Grade 3 (severe edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 30 · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Corneal Edema Grade
POD 30 · Grade 1 (mild edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 30 · Grade 2 (moderate edema)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Corneal Edema Grade
POD 90 · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 90 post-treatmentAnterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.
Outcome measures
| Measure |
Dose 1
n=3 Participants
114ug
IBI-10090: Single intraocular injection
|
Dose 2
n=2 Participants
513ug
IBI-10090: Single intraocular injection
|
Dose 3
n=1 Participants
684ug
IBI-10090: Single intraocular injection
|
|---|---|---|---|
|
Anterior Chamber Cell Grade
POD 1 · Grade 0 (absent)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 1 · Grade 1 (1-5 cells)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 3 · Grade 0 (absent)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 3 · Grade 1 (1-5 cells)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Cell Grade
POD 3 · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 8 · Grade 0 (absent)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Anterior Chamber Cell Grade
POD 8 · Grade 3 (16-30 cells)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 8 · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 15 · Grade 0 (absent)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 30 · Grade 1 (1-5 cells)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 30 · Grade 2 (6-15 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 30 · Grade 3 (16-30 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 90 · Grade 2 (6-15 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
Baseline · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Anterior Chamber Cell Grade
Baseline · Grade 1 (1-5 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
Baseline · Grade 2 (6-15 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
Baseline · Grade 3 (16-30 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
Baseline · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 1 · Grade 2 (6-15 cells)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 1 · Grade 3 (16-30 cells)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Cell Grade
POD 1 · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 3 · Grade 2 (6-15 cells)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 3 · Grade 3 (16-30 cells)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 8 · Grade 1 (1-5 cells)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 8 · Grade 2 (6-15 cells)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 15 · Grade 1 (1-5 cells)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Anterior Chamber Cell Grade
POD 15 · Grade 2 (6-15 cells)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 15 · Grade 3 (16-30 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 15 · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 30 · Grade 0 (absent)
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Anterior Chamber Cell Grade
POD 30 · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 90 · Grade 0 (absent)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Anterior Chamber Cell Grade
POD 90 · Grade 1 (1-5 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 90 · Grade 3 (16-30 cells)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anterior Chamber Cell Grade
POD 90 · Grade 4 (hypopyon)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose 1
n=3 participants at risk
114ug dose group
|
Dose 2
n=2 participants at risk
513ug dose group
|
Dose 3
n=1 participants at risk
684ug dose group
|
|---|---|---|---|
|
General disorders
nasopharyngitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
|
General disorders
skin infection
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
General disorders
rash
|
0.00%
0/3
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
Additional Information
Regulatory Affairs Specialist
Eyepoint Pharmaceuticals, Inc.
Phone: 6179726318
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place