Trial Outcomes & Findings for Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy (NCT NCT02161380)
NCT ID: NCT02161380
Last Updated: 2025-06-05
Results Overview
Number of treatment-related adverse events will be assessed as per investigator with respective to relationship to the investigative product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
3 years
Results posted on
2025-06-05
Participant Flow
Participants were enrolled at Bascom Palmer Eye Institute (Single institution study) in Florida, United States(US) from 14 July 2014 to 18 Nov 2020.
A total of 28 participants with G11778A Leber Hereditary Optic Neuropathy (LHON) were enrolled in the study. They were distributed in the following groups: chronic bilateral visual loss \> 12 months (group 1, n=11), acute bilateral visual loss \< 12 months (group 2, n=9), or unilateral visual loss (group 3, n=8). Each participant received a unilateral intravitreal injection. Group 1 was treated with low, medium, high and higher dose, group 2 and 3 were treated with low, medium, or higher dose.
Participant milestones
| Measure |
Low-dose (1.18x10e9 vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
|
Medium Dose (5.81x10e9 vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
|
High Dose (2.40x10e10 vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 2.40x10e10 vg.
|
Higher Dose (1x10e11vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Unilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
3
|
7
|
|
Overall Study
Chronic Bilateral
|
3
|
3
|
3
|
2
|
|
Overall Study
Acute Bilateral
|
3
|
3
|
0
|
3
|
|
Overall Study
Acute Unilateral
|
3
|
3
|
0
|
2
|
|
Overall Study
COMPLETED
|
9
|
8
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Low-dose (1.18x10e9 vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
|
Medium Dose (5.81x10e9 vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
|
High Dose (2.40x10e10 vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 2.40x10e10 vg.
|
Higher Dose (1x10e11vg)
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Unilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy
Baseline characteristics by cohort
| Measure |
Low-dose (1.18x10e9 vg)
n=9 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
|
Medium Dose (5.81x10e9 vg)
n=9 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
|
High Dose (2.40x10e10 vg)
n=3 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 2.40x10e10 vg.
|
Higher Dose (1x10e11vg)
n=7 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Unilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.44 years
n=5 Participants
|
25.22 years
n=7 Participants
|
25.66 years
n=5 Participants
|
34.14 years
n=4 Participants
|
31.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 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
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 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
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: One subject for medium dose was a loss to follow up after month 06. One subject for low dose missed visits for month 12, month 24 and month 36
Number of treatment-related adverse events will be assessed as per investigator with respective to relationship to the investigative product.
Outcome measures
| Measure |
Low-dose (1.18x10e9 vg)
n=8 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
|
Medium Dose (5.81x10e9 vg)
n=8 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
|
High Dose (2.40x10e10 vg)
n=3 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 2.40x10e10 vg
|
Higher Dose (1x10e11vg)
n=7 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Unilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
|
|---|---|---|---|---|
|
Number of Treatment Related Adverse Events
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: up to 36 months after treatmentPopulation: One subject for low dose missed visits 12, 24, and 36 months but he completed the majority of the other study visits. One subject for medium dose was a loss to follow up after visit 6 months. One subject for higher dose missed a visit 12 months to the COVID-19 pandemic.
Best-corrected visual acuity(BCVA) was tested using the ETDRS Chart. The LogMAR visual acuity scale was adapted from the ETDRS chart to facilitate statistical analysis. Longitudinal analyses of BCVA changes at months 12, 24, and 36 versus baseline 2 were performed.
Outcome measures
| Measure |
Low-dose (1.18x10e9 vg)
n=8 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
|
Medium Dose (5.81x10e9 vg)
n=8 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
|
High Dose (2.40x10e10 vg)
n=3 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 2.40x10e10 vg
|
Higher Dose (1x10e11vg)
n=7 Participants
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Unilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
|
|---|---|---|---|---|
|
Best-corrected Visual Acuity
12 Months/Acute Bilateral Severe Vision
|
-0.54 logMar
Standard Deviation 0.43
|
0.07 logMar
Standard Deviation 0.18
|
—
|
0.26 logMar
Standard Deviation 0.23
|
|
Best-corrected Visual Acuity
36 Months/Chronic Bilateral Severe Vision
|
-0.19 logMar
Standard Deviation 0.39
|
-0.25 logMar
Standard Deviation 0.39
|
-0.40 logMar
Standard Deviation 0.22
|
-0.06 logMar
Standard Deviation 0.11
|
|
Best-corrected Visual Acuity
12 Months/Chronic Bilateral Severe Vision
|
0.03 logMar
Standard Deviation 0.06
|
-0.26 logMar
Standard Deviation 0.42
|
-0.39 logMar
Standard Deviation 0.25
|
-0.007 logMar
Standard Deviation 0.13
|
|
Best-corrected Visual Acuity
12 Months/Acute Unilateral Severe Vision
|
1.08 logMar
Standard Deviation 0.17
|
1.29 logMar
Standard Deviation 0.53
|
—
|
1.09 logMar
Standard Deviation 0.30
|
|
Best-corrected Visual Acuity
24 Months/Chronic Bilateral Severe Vision
|
-0.19 logMar
Standard Deviation 0.39
|
-0.23 logMar
Standard Deviation 0.14
|
-0.41 logMar
Standard Deviation 0.23
|
-0.07 logMar
Standard Deviation 0.13
|
|
Best-corrected Visual Acuity
24 Months/Acute Bilateral Severe Vision
|
-0.95 logMar
Standard Deviation 0.61
|
-0.23 logMar
Standard Deviation 0.36
|
—
|
-0.11 logMar
Standard Deviation 0.46
|
|
Best-corrected Visual Acuity
24 Months/Acute Unilateral Severe Vision
|
0.95 logMar
Standard Deviation 0.21
|
1.47 logMar
Standard Deviation 0.44
|
—
|
0.83 logMar
Standard Deviation 0.24
|
|
Best-corrected Visual Acuity
36 Months/Acute Bilateral Severe Vision
|
-1.01 logMar
Standard Deviation 0.63
|
0.00 logMar
Standard Deviation 0.14
|
—
|
-0.16 logMar
Standard Deviation 0.65
|
|
Best-corrected Visual Acuity
36 Months/Acute Unilateral Severe Vision
|
1.03 logMar
Standard Deviation 0.24
|
1.49 logMar
Standard Deviation 0.40
|
—
|
0.49 logMar
Standard Deviation 0.24
|
Adverse Events
Low-dose (1.18x10e9 vg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Medium Dose (5.81x10e9 vg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
High Dose (2.40x10e10 vg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Higher Dose (1x10e11vg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-dose (1.18x10e9 vg)
n=9 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
|
Medium Dose (5.81x10e9 vg)
n=9 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
|
High Dose (2.40x10e10 vg)
n=3 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 2.40x10e10 vg.
|
Higher Dose (1x10e11vg)
n=7 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Unilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
|
|---|---|---|---|---|
|
Eye disorders
Visual Acuity Loss
|
11.1%
1/9 • Number of events 2 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
11.1%
1/9 • Number of events 1 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
0.00%
0/3 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
0.00%
0/7 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
Other adverse events
| Measure |
Low-dose (1.18x10e9 vg)
n=9 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 1.18x10e9 vg.
|
Medium Dose (5.81x10e9 vg)
n=9 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Bilateral Severe Vision Loss were administrated 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
Participants with Acute Unilateral Severe Vision Loss were administered 200 µL of scAAV2-P1ND4v2 containing a dose of 5.81x10e9 vg.
|
High Dose (2.40x10e10 vg)
n=3 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 2.40x10e10 vg.
|
Higher Dose (1x10e11vg)
n=7 participants at risk
Participants with Chronic Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Bilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
Participants with Acute Unilateral Severe Vision Loss were administered 100 µL of scAAV2-P1ND4v2 containing a dose of 1x10e11vg.
|
|---|---|---|---|---|
|
Eye disorders
Uveitis
|
11.1%
1/9 • Number of events 2 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
11.1%
1/9 • Number of events 1 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
33.3%
1/3 • Number of events 1 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
71.4%
5/7 • Number of events 5 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
|
Eye disorders
Corneal Abrasion
|
11.1%
1/9 • Number of events 1 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
0.00%
0/9 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
0.00%
0/3 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
14.3%
1/7 • Number of events 1 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
|
Metabolism and nutrition disorders
Elevated Liver Enzymes
|
11.1%
1/9 • Number of events 1 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
22.2%
2/9 • Number of events 2 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
0.00%
0/3 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
14.3%
1/7 • Number of events 1 • 3 Years
Participants were followed for AE for 3 years. In addition to the SAE definition for clinicaltrial.gov, this study also considered an SAE a decrease in acuity in the injected eye to 0.3 logMAR units (15-letter equivalent) worse than the worst acuity measured in the uninjected fellow eye at the current or any prior study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place