Trial Outcomes & Findings for Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR) (NCT NCT03252847)
NCT ID: NCT03252847
Last Updated: 2025-01-08
Results Overview
The primary outcome is defined as any of the below occurring during the 9 weeks following administration, at least possibly related to the Advanced Therapy Investigational Medicinal Product (ATIMP), not surgery alone: * Reduction in visual acuity by 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more * Severe unresponsive inflammation * Infective endophthalmitis * Ocular malignancy * Grade III or above non-ocular Suspected Unexpected Serious Adverse Reaction (SUSAR)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
9 weeks
Results posted on
2025-01-08
Participant Flow
Participants were recruited from 5 sites (2 in the UK and 3 in the US) between 31 Jul 2017 and 18 Nov 2021. 49 participants were enrolled in the study; 4 participants discontinued before receiving treatment. The study consisted of 2 phases: dose escalation (Phase 1) followed by dose expansion (Phase 2). In Phase 1, 13 participants enrolled in 1 of 3 treatment groups. In Phase 2, 36 participants were randomized to an active treatment arm or a control arm with treatment deferred for 6 months.
Participant milestones
| Measure |
Phase 1: Immediate Low Dose AAV5-hRKp.RPGR
Subretinal administration of a single low dose of AAV5-hRKp.RPGR in Phase 1 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 1: Immediate Intermediate Dose AAV5-hRKp.RPGR
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR in Phase 1 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 1: Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR in Phase 1 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Immediate Low Dose AAV5-hRKp.RPGR
Subretinal administration of a single low dose of AAV5-hRKp.RPGR in Phase 2 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Immediate Intermediate Dose AAV5-hRKp.RPGR
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR in Phase 2 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR in Phase 2 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Deferred Group
Treatment of participants in this Phase 2 study group was deferred for 6 months
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
3
|
8
|
10
|
1
|
13
|
|
Overall Study
COMPLETED
|
3
|
7
|
2
|
8
|
9
|
1
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Immediate Low Dose AAV5-hRKp.RPGR
Subretinal administration of a single low dose of AAV5-hRKp.RPGR in Phase 1 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 1: Immediate Intermediate Dose AAV5-hRKp.RPGR
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR in Phase 1 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 1: Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR in Phase 1 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Immediate Low Dose AAV5-hRKp.RPGR
Subretinal administration of a single low dose of AAV5-hRKp.RPGR in Phase 2 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Immediate Intermediate Dose AAV5-hRKp.RPGR
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR in Phase 2 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR in Phase 2 of the study.
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
|
Phase 2: Deferred Group
Treatment of participants in this Phase 2 study group was deferred for 6 months
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other: Patient decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR)
Baseline characteristics by cohort
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=11 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=17 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
n=4 Participants
Subretinal administration of a single high dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
n=13 Participants
Treatment of participants in this Phase 2 study group was deferred for 6 months
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
31 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: The primary endpoint was analyzed for participants in the dose escalation phase (i.e., study Phase 1) only
The primary outcome is defined as any of the below occurring during the 9 weeks following administration, at least possibly related to the Advanced Therapy Investigational Medicinal Product (ATIMP), not surgery alone: * Reduction in visual acuity by 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more * Severe unresponsive inflammation * Infective endophthalmitis * Ocular malignancy * Grade III or above non-ocular Suspected Unexpected Serious Adverse Reaction (SUSAR)
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=3 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=4 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
n=3 Participants
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Number of Participants Meeting the Primary Outcome Defined as Any of the Below Events Occurring During the 9 Weeks Following Administration, at Least Possibly Related to the Advanced Therapy Investigational Medicinal Product (ATIMP), Not Surgery Alone.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: It was prespecified that the results of participants assigned to the low and intermediate dose groups in study Phase 1 and Phase 2 would be pooled and compared to the results of participants in the deferred group before treatment. Data were available for 25 participants in the Immediate Treatment Group and 13 participants in the Deferred Treatment Group
Change from baseline to Week 26 in best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) chart letter score. The direction of improvement from baseline is an increase in the number of ETDRS letters read over time.
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=25 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=13 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Improvements in Visual Function as Assessed by Visual Acuity
|
0.6 Number of EDTRS letters
Standard Deviation 4.74
|
-3.2 Number of EDTRS letters
Standard Deviation 3.87
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: It was prespecified that the results of participants assigned to the low and intermediate dose groups in study Phase 1 and Phase 2 would be pooled and compared to the results of participants in the deferred group before treatment. Data were available for 23 participants in the Immediate Treatment Group and 10 participants in the Deferred Treatment Group.
The number of responders in point-by-point data in Static Perimetry within the full visual field over time. A responder at a single time point is defined as a participant with at least 5 of the same loci with ≥7 dB improvement from baseline at the specific time point and one time point prior.
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=23 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=10 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Improvements in Retinal Function as Assessed by Static Perimetry
|
6 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: It was prespecified that the results of participants assigned to the low and intermediate dose groups in study Phase 2 would be pooled and compared to the results of participants in the deferred group before treatment. Sixteen participants in the Immediate Treatment Group and all 9 participants in the Deferred Treatment Group completed the LLQ at baseline and Week 26.
Change from baseline to Week 26 in LLQ Emotional Distress Domain Score in adults. LLQ uses a scale from 0 to 100, with higher scores reflecting less impairment. A positive change from baseline reflects improvement, and a negative reflects worsening.
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=16 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=9 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Quality of Life Measured by the Low Luminance Questionnaire (LLQ) Emotional Distress Domain Score
|
2.344 Units on a scale
Standard Deviation 20.1395
|
-1.389 Units on a scale
Standard Deviation 8.7152
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: It was prespecified that the results of participants assigned to the low and intermediate dose groups in study Phase 2 would be pooled and compared to the results of participants in the deferred group before treatment. Sixteen participants in the Immediate Treatment Group and all 9 participants in the Deferred Treatment Group completed the LLQ at baseline and Week 26.
Change from baseline to Week 26 in LLQ Extreme Lighting Domain Score in adults. LLQ uses a scale from 0 to 100, with higher scores reflecting less impairment. A positive change from baseline reflects improvement, and a negative reflects worsening.
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=16 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=9 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Quality of Life Measured by the Low Luminance Questionnaire (LLQ) Extreme Lighting Domain Score
|
2.956 Units on a scale
Standard Deviation 9.7080
|
-8.059 Units on a scale
Standard Deviation 5.8453
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: It was prespecified that the results of participants assigned to the low and intermediate dose groups in study Phase 2 would be pooled and compared to the results of participants in the deferred group before treatment. Sixteen participants in the Immediate Treatment Group and all 9 participants in the Deferred Treatment Group completed the LLQ at baseline and Week 26.
Change from baseline to Week 26 in LLQ General Dim Lighting Domain score in adults. LLQ uses a scale from 0 to 100, with higher scores reflecting less impairment. A positive change from baseline reflects improvement, and a negative reflects worsening.
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=16 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=9 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Quality of Life Measured by the Low Luminance Questionnaire (LLQ) General Dim Lighting Domain Score
|
4.115 Units on a scale
Standard Deviation 14.9706
|
1.852 Units on a scale
Standard Deviation 11.8056
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: It was prespecified that the results of participants assigned to the low and intermediate dose groups in study Phase 2 would be pooled and compared to the results of participants in the deferred group before treatment. Sixteen participants in the Immediate Treatment Group and all 9 participants in the Deferred Treatment Group completed the LLQ at baseline and Week 26.
Change from baseline to Week 26 in LLQ Mobility Domain Score in adults. LLQ uses a scale from 0 to 100, with higher scores reflecting less impairment. A positive change from baseline reflects improvement, and a negative reflects worsening.
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=16 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=9 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Quality of Life Measured by the Low Luminance Questionnaire (LLQ) Mobility Domain Score
|
5.729 Units on a scale
Standard Deviation 15.8753
|
0.926 Units on a scale
Standard Deviation 6.5145
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: It was prespecified that the results of participants assigned to the low and intermediate dose groups in study Phase 2 would be pooled and compared to the results of participants in the deferred group before treatment. Sixteen participants in the Immediate Treatment Group and all 9 participants in the Deferred Treatment Group completed the LLQ at baseline and Week 26.
Change from baseline to Week 26 in LLQ Peripheral Vision Domain Score in adults. LLQ uses a scale from 0 to 100, with higher scores reflecting less impairment. A positive change from baseline reflects improvement, and a negative reflects worsening.
Outcome measures
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=16 Participants
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=9 Participants
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
Subretinal administration of a single high dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group
Treatment of participants in this group was deferred for 6 months
|
|---|---|---|---|---|
|
Quality of Life Measured by the Low Luminance Questionnaire (LLQ) Peripheral Vision Domain Score
|
1.563 Units on a scale
Standard Deviation 18.8116
|
-1.852 Units on a scale
Standard Deviation 9.1076
|
—
|
—
|
Adverse Events
Immediate Low Dose AAV5-hRKp.RPGR
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Immediate Intermediate Dose AAV5-hRKp.RPGR
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Immediate High Dose AAV5-hRKp.RPGR
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Deferred Group - Before Treatment (Control Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Deferred Group - Low Dose AAV5-hRKp.RPGR - After Treatment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Deferred Group - Intermediate Dose AAV5-hRKp.RPGR - After Treatment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=11 participants at risk
Subretinal administration of a single low dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=17 participants at risk
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
n=4 participants at risk
Subretinal administration of a single high dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group - Before Treatment (Control Group)
n=13 participants at risk
Treatment of participants in this Phase 2 group was deferred for 6 months. Data from these deferred-treatment participants (i.e., the Control Group) are included from the signing of the ICF until the time of surgery
|
Deferred Group - Low Dose AAV5-hRKp.RPGR - After Treatment
n=7 participants at risk
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene. Treatment of participants in this Phase 2 group was deferred for 6 months. Data from these deferred treatment participants are included from the time of surgery until the end of the study.
|
Deferred Group - Intermediate Dose AAV5-hRKp.RPGR - After Treatment
n=6 participants at risk
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
Treatment of participants in this Phase 2 group was deferred for 6 months. Data from these deferred treatment participants are included from the time of surgery until the end of the study.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Retinal Detachment
|
9.1%
1/11 • Number of events 1 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Uveitis
|
9.1%
1/11 • Number of events 1 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
14.3%
1/7 • Number of events 1 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
Other adverse events
| Measure |
Immediate Low Dose AAV5-hRKp.RPGR
n=11 participants at risk
Subretinal administration of a single low dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate Intermediate Dose AAV5-hRKp.RPGR
n=17 participants at risk
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Immediate High Dose AAV5-hRKp.RPGR
n=4 participants at risk
Subretinal administration of a single high dose of AAV5-hRKp.RPGR in either Phase 1 or Phase 2 of the study (prespecified pooling).
AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene
|
Deferred Group - Before Treatment (Control Group)
n=13 participants at risk
Treatment of participants in this Phase 2 group was deferred for 6 months. Data from these deferred-treatment participants (i.e., the Control Group) are included from the signing of the ICF until the time of surgery
|
Deferred Group - Low Dose AAV5-hRKp.RPGR - After Treatment
n=7 participants at risk
Subretinal administration of a single low dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene. Treatment of participants in this Phase 2 group was deferred for 6 months. Data from these deferred treatment participants are included from the time of surgery until the end of the study.
|
Deferred Group - Intermediate Dose AAV5-hRKp.RPGR - After Treatment
n=6 participants at risk
Subretinal administration of a single intermediate dose of AAV5-hRKp.RPGR AAV5-hRKp.RPGR: AAV gene therapy for defects in the RPGR gene.
Treatment of participants in this Phase 2 group was deferred for 6 months. Data from these deferred treatment participants are included from the time of surgery until the end of the study.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Conjunctival abrasion
|
9.1%
1/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
11.8%
2/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Investigations
Intraocular pressure increased
|
45.5%
5/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
52.9%
9/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
50.0%
2/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
57.1%
4/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
33.3%
2/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
5.9%
1/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
16.7%
1/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
5.9%
1/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Investigations
Intraocular pressure decreased
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
5.9%
1/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
28.6%
2/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
11.8%
2/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
14.3%
1/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
16.7%
1/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Conjunctival haemorrhage
|
72.7%
8/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
64.7%
11/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
100.0%
4/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
28.6%
2/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
50.0%
3/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Anterior chamber cell
|
36.4%
4/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
52.9%
9/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
75.0%
3/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
28.6%
2/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
33.3%
2/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Visual acuity reduced
|
54.5%
6/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
47.1%
8/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
50.0%
2/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
85.7%
6/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
100.0%
6/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Eye inflammation
|
27.3%
3/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
29.4%
5/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
28.6%
2/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
16.7%
1/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Foreign body sensation in eyes
|
9.1%
1/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
29.4%
5/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
50.0%
2/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Ocular discomfort
|
27.3%
3/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
23.5%
4/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
25.0%
1/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
28.6%
2/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
16.7%
1/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Cystoid macular oedema
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
17.6%
3/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
25.0%
1/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Eye pain
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
17.6%
3/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
28.6%
2/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
16.7%
1/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Conjunctival hyperaemia
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
11.8%
2/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
42.9%
3/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Posterior capsule opacification
|
9.1%
1/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
17.6%
3/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
23.5%
4/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
28.6%
2/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Uveitis
|
0.00%
0/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
11.8%
2/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
50.0%
2/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Cataract
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
25.0%
1/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Retinal cyst
|
0.00%
0/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
11.8%
2/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
25.0%
1/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Eye disorders
Vitreous floaters
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
7.7%
1/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
5.9%
1/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
25.0%
1/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Skin and subcutaneous tissue disorders
Acne
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
17.6%
3/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
14.3%
1/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
16.7%
1/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
11.8%
2/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Metabolism and nutrition disorders
Increased appetite
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
5.9%
1/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
16.7%
1/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
|
Infections and infestations
Rhinitis
|
18.2%
2/11 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
11.8%
2/17 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
50.0%
2/4 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/13 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
14.3%
1/7 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
0.00%
0/6 • Data are included from the signing of the ICF until the Month 12 visit.
There were 3 SAEs (all non-fatal) reported during the study: 2 in the immediate treatment group (preferred terms retinal detachment and uveitis) and 1 in the deferred treatment group after surgery (preferred term intraocular pressure increased).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place