Trial Outcomes & Findings for Gevokizumab for Active Scleritis (NCT NCT01835132)
NCT ID: NCT01835132
Last Updated: 2018-07-06
Results Overview
Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can't be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show).
COMPLETED
PHASE1/PHASE2
8 participants
Baseline and Week 16
2018-07-06
Participant Flow
Initial Phase: All participants have injections at Baseline, Wks 4, 8, and 12 with follow up visits at Wks 2, 16, and 28. 1st Extension Phase: If improved by Wk 16, visits every 4 wks until Wk 36 and then 2 visits at Wks 40 and 52. As-needed 2nd Extension Phase: At Week 52, if eligible, may continue with injections at Wks 52, 54, 58 and 62.
Participant milestones
| Measure |
Gevokizumab
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Initial Phase
STARTED
|
8
|
|
Initial Phase
COMPLETED
|
6
|
|
Initial Phase
NOT COMPLETED
|
2
|
|
1st Extension Phase
STARTED
|
6
|
|
1st Extension Phase
COMPLETED
|
6
|
|
1st Extension Phase
NOT COMPLETED
|
0
|
|
2nd Extension Phase - As Needed (PRN)
STARTED
|
3
|
|
2nd Extension Phase - As Needed (PRN)
COMPLETED
|
3
|
|
2nd Extension Phase - As Needed (PRN)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Gevokizumab
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Initial Phase
Insufficient Therapeutic Response
|
2
|
Baseline Characteristics
Gevokizumab for Active Scleritis
Baseline characteristics by cohort
| Measure |
Gevokizumab
n=8 Participants
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
59.88 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can't be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show).
Outcome measures
| Measure |
Gevokizumab
n=8 Participants
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Number of Participants With at Least a 2-step Reduction or Reduction to Grade 0 in Scleral Inflammation in the Study Eye (or Eyes), According to the National Eye Institute (NEI) Photographic Scleritis Grading System, on or Before the Week 16 Visit.
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 2 Compared to Baseline
|
-1.00 ETDRS letters
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 4 Compared to Baseline
|
-1.78 ETDRS letters
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 8 Compared to Baseline
|
0.78 ETDRS letters
Standard Deviation 4.84
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 12 Compared to Baseline
|
0.11 ETDRS letters
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 16 Compared to Baseline
|
1.00 ETDRS letters
Standard Deviation 6.61
|
SECONDARY outcome
Timeframe: Baseline and Week 20Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 20 Compared to Baseline
|
1.33 ETDRS letters
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 24 Compared to Baseline
|
-0.67 ETDRS letters
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 28 Compared to Baseline
|
1.00 ETDRS letters
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Baseline and Week 32Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 32 Compared to Baseline
|
3.00 ETDRS letters
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 36 Compared to Baseline
|
1.83 ETDRS letters
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Baseline and Week 40Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 40 Compared to Baseline
|
2.67 ETDRS letters
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52 Compared to Baseline
|
0.17 ETDRS letters
Standard Deviation 6.43
|
SECONDARY outcome
Timeframe: Baseline and Week 52APopulation: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52A Compared to Baseline
|
-8.00 ETDRS letters
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 54 Compared to Baseline
|
-0.67 ETDRS letters
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: Baseline and Week 58Population: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 58 Compared to Baseline
|
-1.33 ETDRS letters
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: Baseline and Week 62Population: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 62 Compared to Baseline
|
-1.33 ETDRS letters
Standard Deviation 5.03
|
SECONDARY outcome
Timeframe: Baseline and Final VisitPopulation: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Visual Acuity in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline
|
-2.00 ETDRS letters
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 2 Compared to Baseline
|
0.67 mmHg
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 4 Compared to Baseline
|
0.67 mmHg
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 8 Compared to Baseline
|
1.11 mmHg
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 12 Compared to Baseline
|
1.00 mmHg
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 16 Compared to Baseline
|
1.56 mmHg
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Baseline and Week 20Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 20 Compared to Baseline
|
1.33 mmHg
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Mean Change in Intraocular pressure (IOP) is measured and reported as change in IOP between baseline and 24 weeks in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 24 Compared to Baseline
|
0.78 mmHg
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 28 Compared to Baseline
|
1.11 mmHg
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Baseline and Week 32Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 32 Compared to Baseline
|
2.67 mmHg
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 36 Compared to Baseline
|
2.17 mmHg
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: Baseline and Week 40Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 40 Compared to Baseline
|
0.50 mmHg
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=6 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52 Compared to Baseline
|
1.83 mmHg
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Baseline and Week 52APopulation: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62. Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52A Compared to Baseline
|
-0.67 mmHg
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 54 Compared to Baseline
|
1.33 mmHg
Standard Deviation 4.16
|
SECONDARY outcome
Timeframe: Baseline and Week 58Population: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 58 Compared to Baseline
|
1.33 mmHg
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: Baseline and Week 62Population: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 62 Compared to Baseline
|
0.67 mmHg
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline and Final VisitPopulation: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Gevokizumab
n=3 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline
|
1.33 mmHg
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Post-injection through study completion, up to 78 weeks per participantPopulation: Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
Gevokizumab
n=9 eyes
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Number of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.
Scleral inflammation was summarized on an ordinal scale as either none, minimal/trace, mild, moderate, severe or necrotizing inflammation in the four quadrants of the study eye (superonasal \[SN\], superotemporal \[ST\], inferotemporal \[IT\], and inferonasal \[IN\]) for each participant at each visit. The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.
Outcome measures
Outcome data not reported
Adverse Events
Gevokizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gevokizumab
n=8 participants at risk
Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
General disorders
Asthenia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Investigations
Bacterial test
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Investigations
Biopsy skin
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Eye disorders
Corneal thinning
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Investigations
Hemoglobin urine present
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Gastrointestinal disorders
Haemorrhoids
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Investigations
Hepatic enzyme increased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Infections and infestations
Hordeolum
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Infections and infestations
Infection
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
12.5%
1/8 • Number of events 3 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Injury, poisoning and procedural complications
Joint injury
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Injury, poisoning and procedural complications
Laceration
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Injury, poisoning and procedural complications
Limb injury
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Eye disorders
Ocular hyperaemia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Skin and subcutaneous tissue disorders
Pruritis generalized
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Eye disorders
Scleral thinning
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
General disorders
Injection site discomfort
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from baseline until study completion, up to 78 weeks (wks) per participant. Participants in the 2nd extension phase had a final safety visit at least 16 wks following their last injection in the 2nd extension phase at Wk 62.
|
Additional Information
H. Nida Sen, MD, MHSc, Principal Investigator, NEI
National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place