Trial Outcomes & Findings for Gene Therapy for Achromatopsia (CNGB3) (NCT NCT03001310)
NCT ID: NCT03001310
Last Updated: 2023-03-08
Results Overview
The primary outcome is defined as any of the below occurring during the 6 weeks following administration, at least possibly related to the Advanced Therapy Investigational Medicinal Products (ATIMP), not surgery alone: * Reduction in visual acuity by 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more that fails to resolve to within 15 letters of baseline in a 4-week period once prophylactic treatment commences * 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
23 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-03-08
Participant Flow
Participants were recruited from medical centers in the United Kingdom (UK) and the United States (US). A total of 23 participants were enrolled in the study.
Participant milestones
| Measure |
Low Dose AAV - CNGB3
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
12
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gene Therapy for Achromatopsia (CNGB3)
Baseline characteristics by cohort
| Measure |
Low Dose AAV - CNGB3
n=3 Participants
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=12 Participants
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
n=3 Participants
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=5 Participants
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 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
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 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
|
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
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
11 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
20 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe primary outcome is defined as any of the below occurring during the 6 weeks following administration, at least possibly related to the Advanced Therapy Investigational Medicinal Products (ATIMP), not surgery alone: * Reduction in visual acuity by 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more that fails to resolve to within 15 letters of baseline in a 4-week period once prophylactic treatment commences * Severe unresponsive inflammation * Infective endophthalmitis * Ocular malignancy * Grade III or above non-ocular Suspected Unexpected Serious Adverse Reaction (SUSAR)
Outcome measures
| Measure |
Low Dose AAV - CNGB3
n=3 Participants
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=12 Participants
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
n=3 Participants
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=5 Participants
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
|---|---|---|---|---|
|
Number of Participants Meeting the Primary Outcome Defined as Any of the Below Events Occurring During the 6 Weeks Following Administration, at Least Possibly Related to the Advanced Therapy Investigational Medicinal Products (ATIMP), Not Surgery Alone.
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 22 of the 23 participants performed the visual acuity assessment at baseline and Week 24.
Change from baseline to Week 24 in best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) chart letter score in the treated eye. The direction of improvement from baseline is an increase in the number of ETDRS letters read over time.
Outcome measures
| Measure |
Low Dose AAV - CNGB3
n=3 Participants
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=11 Participants
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
n=3 Participants
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=5 Participants
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
|---|---|---|---|---|
|
Improvements in Visual Function as Assessed by Visual Acuity
|
-0.44 number of ETDRS letters
Interval -2.0 to 1.3
|
-0.58 number of ETDRS letters
Interval -4.3 to 3.3
|
1.78 number of ETDRS letters
Interval 0.3 to 4.7
|
1.45 number of ETDRS letters
Interval -4.0 to 5.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 20 of the 23 participants had mean retinal sensitivity data available at both baseline and Week 24 in the treated eye.
Change from baseline to Week 24 in mean retinal sensitivity in the treated eye. The direction of improvement is an increase in sensitivity.
Outcome measures
| Measure |
Low Dose AAV - CNGB3
n=3 Participants
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=9 Participants
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
n=3 Participants
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=5 Participants
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
|---|---|---|---|---|
|
Improvements in Retinal Function as Assessed by Static Perimetry
|
-1.58 decibel
Interval -3.1 to 0.0
|
-0.39 decibel
Interval -2.4 to 1.8
|
8.13 decibel
Interval 1.7 to 11.4
|
-0.77 decibel
Interval -7.1 to 3.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: EQ-VAS data were available for 11 children/adolescents enrolled in the study.
Change from baseline to Week 24 in EuroQol-5D-Y Visual Analogue Scale (EQ-VAS) in children and adolescents. EQ-VAS uses a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A positive change from baseline reflects improvement and a negative change from baseline reflects worsening.
Outcome measures
| Measure |
Low Dose AAV - CNGB3
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=7 Participants
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
n=3 Participants
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=1 Participants
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
|---|---|---|---|---|
|
Quality of Life Measured by QoL Questionnaires in Children and Adolescents
|
—
|
6.9 units on a scale
Interval -2.0 to 20.0
|
2.3 units on a scale
Interval -3.0 to 10.0
|
-9.0 units on a scale
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: EQ-VAS data were available for 11 adults enrolled in the study.
Change from baseline to Week 24 in EuroQol-5D-5L Visual Analogue Scale (EQ-VAS) in adults. EQ-VAS uses a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A positive change from baseline reflects improvement and a negative change from baseline reflects worsening.
Outcome measures
| Measure |
Low Dose AAV - CNGB3
n=3 Participants
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=4 Participants
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=4 Participants
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
|---|---|---|---|---|
|
Quality of Life Measured by QoL Questionnaires in Adults
|
0.0 units on a scale
Interval -10.0 to 10.0
|
-3.8 units on a scale
Interval -10.0 to 5.0
|
—
|
4.3 units on a scale
Interval -5.0 to 20.0
|
Adverse Events
Low Dose AAV - CNGB3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Intermediate Dose AAV-CNGB3
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Other Dose - AAV - CNGB3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High Dose AAV - CNGB3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Total
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose AAV - CNGB3
n=3 participants at risk
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=12 participants at risk
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
n=3 participants at risk
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=5 participants at risk
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Total
n=23 participants at risk
Safety Analysis Set
|
|---|---|---|---|---|---|
|
Eye disorders
Uveitis
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/5 • 6 months
|
4.3%
1/23 • 6 months
|
Other adverse events
| Measure |
Low Dose AAV - CNGB3
n=3 participants at risk
Subretinal administration of a single low dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Intermediate Dose AAV-CNGB3
n=12 participants at risk
Subretinal administration of a single intermediate dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Other Dose - AAV - CNGB3
n=3 participants at risk
Subretinal administration of a single other dose (between intermediate and high dose levels) of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
High Dose AAV - CNGB3
n=5 participants at risk
Subretinal administration of a single high dose of adeno-associated virus AAV-CNGB3; AAV-CNGB3: AAV gene therapy for defects in CNGB3 gene
|
Total
n=23 participants at risk
Safety Analysis Set
|
|---|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
100.0%
3/3 • 6 months
|
83.3%
10/12 • 6 months
|
66.7%
2/3 • 6 months
|
100.0%
5/5 • 6 months
|
87.0%
20/23 • 6 months
|
|
Eye disorders
Lenticular opacities
|
66.7%
2/3 • 6 months
|
58.3%
7/12 • 6 months
|
100.0%
3/3 • 6 months
|
60.0%
3/5 • 6 months
|
65.2%
15/23 • 6 months
|
|
Eye disorders
Visual acuity reduced
|
66.7%
2/3 • 6 months
|
58.3%
7/12 • 6 months
|
33.3%
1/3 • 6 months
|
100.0%
5/5 • 6 months
|
65.2%
15/23 • 6 months
|
|
Eye disorders
Subretinal fluid
|
66.7%
2/3 • 6 months
|
33.3%
4/12 • 6 months
|
0.00%
0/3 • 6 months
|
60.0%
3/5 • 6 months
|
39.1%
9/23 • 6 months
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/3 • 6 months
|
58.3%
7/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
34.8%
8/23 • 6 months
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • 6 months
|
41.7%
5/12 • 6 months
|
0.00%
0/3 • 6 months
|
60.0%
3/5 • 6 months
|
34.8%
8/23 • 6 months
|
|
Eye disorders
Chorioretinal folds
|
0.00%
0/3 • 6 months
|
33.3%
4/12 • 6 months
|
0.00%
0/3 • 6 months
|
40.0%
2/5 • 6 months
|
26.1%
6/23 • 6 months
|
|
Eye disorders
Retinal haemorrhage
|
66.7%
2/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
40.0%
2/5 • 6 months
|
26.1%
6/23 • 6 months
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • 6 months
|
25.0%
3/12 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/5 • 6 months
|
17.4%
4/23 • 6 months
|
|
Eye disorders
Eye inflammation
|
33.3%
1/3 • 6 months
|
8.3%
1/12 • 6 months
|
66.7%
2/3 • 6 months
|
0.00%
0/5 • 6 months
|
17.4%
4/23 • 6 months
|
|
Eye disorders
Maculopathy
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/3 • 6 months
|
60.0%
3/5 • 6 months
|
17.4%
4/23 • 6 months
|
|
Eye disorders
Retinal depigmentation
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
66.7%
2/3 • 6 months
|
0.00%
0/5 • 6 months
|
17.4%
4/23 • 6 months
|
|
Eye disorders
Retinal oedema
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
40.0%
2/5 • 6 months
|
17.4%
4/23 • 6 months
|
|
Eye disorders
Retinal tear
|
0.00%
0/3 • 6 months
|
25.0%
3/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
17.4%
4/23 • 6 months
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/5 • 6 months
|
13.0%
3/23 • 6 months
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
13.0%
3/23 • 6 months
|
|
Eye disorders
Vitreous floaters
|
33.3%
1/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/5 • 6 months
|
13.0%
3/23 • 6 months
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Eye disorders
Corneal disorder
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Eye disorders
Retinal disorder
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • 6 months
|
0.00%
0/12 • 6 months
|
0.00%
0/3 • 6 months
|
40.0%
2/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • 6 months
|
25.0%
3/12 • 6 months
|
33.3%
1/3 • 6 months
|
20.0%
1/5 • 6 months
|
26.1%
6/23 • 6 months
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • 6 months
|
33.3%
4/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
21.7%
5/23 • 6 months
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
17.4%
4/23 • 6 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • 6 months
|
33.3%
4/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
21.7%
5/23 • 6 months
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 6 months
|
0.00%
0/12 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Investigations
Intraocular pressure increased
|
66.7%
2/3 • 6 months
|
8.3%
1/12 • 6 months
|
33.3%
1/3 • 6 months
|
40.0%
2/5 • 6 months
|
26.1%
6/23 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
13.0%
3/23 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 6 months
|
16.7%
2/12 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/5 • 6 months
|
8.7%
2/23 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • 6 months
|
8.3%
1/12 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
1/5 • 6 months
|
8.7%
2/23 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place