Trial Outcomes & Findings for Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year (NCT NCT03293524)
NCT ID: NCT03293524
Last Updated: 2026-04-16
Results Overview
The primary efficacy endpoint was the change from baseline of BCVA reported with LogMAR at 1.5-year post-treatment, in the second-affected/not-yet-affected eyes of ND4 LHON patients with vision loss up to one year. LogMAR BCVA was used to represent BCVA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
98 participants
Primary outcome timeframe
at 1.5 years post-treatment, in the second-affected/not-yet affected eyes
Results posted on
2026-04-16
Participant Flow
108 patients (≥ 15 years old) were screened for eligibility in 13 sites (Belgium, France, Italy, Spain, Taiwan, United Kingdom: 1 site each, and the United States: 7 sites). Of these, 98 were randomized: 48 to treatment Arm 1 (GS010-GS010) and 50 to treatment Arm 2 (GS010-placebo). The remaining 10 participants were screen failures.
108 patients with the G11778A mitochondrial point mutation in the ND4 gene and vision loss of up to 1 year in one or both eyes were screened. Screening failures (10) including patients who did not meet inclusion criteria or met exclusion criteria.
Participant milestones
| Measure |
GS010-GS010
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
50
|
|
Overall Study
COMPLETED
|
40
|
36
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
Reasons for withdrawal
| Measure |
GS010-GS010
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Email by patient 9 months after final visit
|
0
|
1
|
|
Overall Study
Non-compliant to visits
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GS010-GS010
n=48 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=50 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Affected eye status
Bilateral
|
47 Participants
n=48 Participants
|
50 Participants
n=50 Participants
|
97 Participants
n=98 Participants
|
|
Durations of disease
|
8.3 Months
STANDARD_DEVIATION 3.4 • n=48 Participants
|
8.3 Months
STANDARD_DEVIATION 3.1 • n=50 Participants
|
8.3 Months
STANDARD_DEVIATION 3.2 • n=98 Participants
|
|
Age, Continuous
Age at screening
|
32.4 years
STANDARD_DEVIATION 14.4 • n=48 Participants
|
31.8 years
STANDARD_DEVIATION 13.4 • n=50 Participants
|
32.1 years
STANDARD_DEVIATION 13.8 • n=98 Participants
|
|
Age, Customized
Between 15 and 18 years
|
3 participants
n=48 Participants
|
7 participants
n=50 Participants
|
10 participants
n=98 Participants
|
|
Age, Customized
Between 18 and 60 years
|
42 participants
n=48 Participants
|
41 participants
n=50 Participants
|
83 participants
n=98 Participants
|
|
Age, Customized
≥ 60 years
|
3 participants
n=48 Participants
|
2 participants
n=50 Participants
|
5 participants
n=98 Participants
|
|
Sex/Gender, Customized
Female
|
11 participants
n=48 Participants
|
9 participants
n=50 Participants
|
20 participants
n=98 Participants
|
|
Sex/Gender, Customized
Male
|
37 participants
n=48 Participants
|
41 participants
n=50 Participants
|
78 participants
n=98 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
East Asia
|
8 Participants
n=48 Participants
|
7 Participants
n=50 Participants
|
15 Participants
n=98 Participants
|
|
Region of Enrollment
Europe
|
11 Participants
n=48 Participants
|
16 Participants
n=50 Participants
|
27 Participants
n=98 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=48 Participants
|
27 Participants
n=50 Participants
|
56 Participants
n=98 Participants
|
|
Age at onset of the disease
|
31.7 years
STANDARD_DEVIATION 14.4 • n=48 Participants
|
31.2 years
STANDARD_DEVIATION 13.4 • n=50 Participants
|
31.5 years
STANDARD_DEVIATION 13.8 • n=98 Participants
|
|
Current alcohol use
≤ 1 drink/day or occasionally :
|
24 Participants
n=48 Participants
|
27 Participants
n=50 Participants
|
51 Participants
n=98 Participants
|
|
Current alcohol use
> 1 to 2 drinks/day :
|
5 Participants
n=48 Participants
|
5 Participants
n=50 Participants
|
10 Participants
n=98 Participants
|
|
Current alcohol use
> 2 drinks/day :
|
2 Participants
n=48 Participants
|
4 Participants
n=50 Participants
|
6 Participants
n=98 Participants
|
|
Current alcohol use
No use :
|
16 Participants
n=48 Participants
|
13 Participants
n=50 Participants
|
29 Participants
n=98 Participants
|
|
Current alcohol use
Missing :
|
1 Participants
n=48 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=98 Participants
|
|
Affected eye status
Unilateral
|
1 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=98 Participants
|
|
Time interval of vision loss between 1st and 2nd-affected eye
|
56.9 days
STANDARD_DEVIATION 66.3 • n=48 Participants
|
61.9 days
STANDARD_DEVIATION 54.1 • n=50 Participants
|
59.4 days
STANDARD_DEVIATION 60.1 • n=98 Participants
|
PRIMARY outcome
Timeframe: at 1.5 years post-treatment, in the second-affected/not-yet affected eyesPopulation: The intent-to-treat analysis (ITT) population consisted of all randomized subjects. The analyses were based on the planned treatment (as randomized) on the primary eye (i.e., second-affected/not-yet-affected eye), unless otherwise specified.
The primary efficacy endpoint was the change from baseline of BCVA reported with LogMAR at 1.5-year post-treatment, in the second-affected/not-yet-affected eyes of ND4 LHON patients with vision loss up to one year. LogMAR BCVA was used to represent BCVA.
Outcome measures
| Measure |
GS010-GS010
n=48 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=50 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Change From Baseline of the Best Corrected Visual Acuity (BCVA) Reported With Log of the Minimal Angle of Resolution (LogMAR) at 1.5 Years Post-treatment, in the Second Affected/Not-yet Affected Eyes
|
-0.09 logMAR
Standard Error 0.072
|
-0.04 logMAR
Standard Error 0.071
|
SECONDARY outcome
Timeframe: at 5 years post-treatment, in the second-affected/not-yet affected eyesPopulation: The intent-to-treat analysis (ITT) population consisted of all randomized subjects. The analyses were based on the planned treatment (as randomized).
Change from baseline of BCVA reported with LogMAR at 5 years post-treatment, in the second-affected/not-yet-affected eyes of ND4 LHON patients with vision loss up to one year. LogMAR BCVA was used to represent BCVA.
Outcome measures
| Measure |
GS010-GS010
n=48 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=50 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Change From Baseline of the BCVA Reported With LogMAR at 5 Years Post-treatment, in the Second Affected/Not-yet Affected Eyes
|
-0.13 LogMAR
Standard Error 0.080
|
-0.05 LogMAR
Standard Error 0.079
|
SECONDARY outcome
Timeframe: From baseline to 5 years post-treatmentPopulation: The intent-to-treat analysis (ITT) population consisted of all randomized subjects. The analyses were based on the planned treatment (as randomized).
Proportion of patients with both eyes off-chart, defined as those patients unable to read letter on the ETDRS chart, who had at least one eye on-chart, defined as those patients able to read letters on the ETDRS chart (at either 4 meters or 1 meter) at 5 years
Outcome measures
| Measure |
GS010-GS010
n=13 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=12 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Proportion of Patients Who Switched From Off-chart Eyes to On-chart Eyes at 5 Years Post-treatment
|
61.54 Percentage of participants
|
33.33 Percentage of participants
|
SECONDARY outcome
Timeframe: From nadir to 5 years post-treatmentPopulation: The intent-to-treat analysis (ITT) population consisted of all randomized subjects. The analyses were based on the planned treatment (as randomized).
Proportion of patients with an improvement of at least -0.3 LogMAR (≥ +15 ETDRS letters) from nadir to year 5 in at least one eye. Nadir was defined for each eye of each subject as the worst value observed from baseline to year 5
Outcome measures
| Measure |
GS010-GS010
n=48 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=50 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Responder Analyses - Improvements From Nadir (Gainer Eyes) at 5 Years
|
68.8 percentage of participants
|
66.0 percentage of participants
|
SECONDARY outcome
Timeframe: From nadir to 5 years post-treatmentPopulation: The intent-to-treat analysis (ITT) population consisted of all randomized subjects. The analyses were based on the planned treatment (as randomized).
Proportion of patients with clinically relevant recovery (CRR) from nadir that was defined as patient with a CRR in at least one eye - Patient with at least one eye which was on chart at nadir, and which had an improvement of at least -0.2 LogMAR from nadir, or which was off-chart at nadir but became on-chart
Outcome measures
| Measure |
GS010-GS010
n=48 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=50 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Responder Analyses - Clinically Relevant Recovery From Nadir at 5 Years
|
75.0 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline nadir to 5 years post-treatmentPopulation: The intent-to-treat analysis (ITT) population consisted of all randomized subjects. The analyses were based on the planned treatment (as randomized).
Proportion of patients who had clinically relevant stabilization (CRS), defined as eyes with LogMAR BCVA \< 1 at baseline and at 5 years post-treatment or had a clinically relevant recovery (CRR) from nadir. The best response observed in either eye was considered.
Outcome measures
| Measure |
GS010-GS010
n=48 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=50 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Responder Analyses- Clinically Relevant Benefit at 5 Years
|
75.0 percentage of participants
|
62.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to 5 years post-treatmentPopulation: The intent-to-treat analysis (ITT) population consisted of all randomized subjects. The analyses were based on the planned treatment (as randomized). Participants in the ITT population without a Year 5 assessment were not included in the analysis.
Change from baseline to 5 years follow up in the Visual Function Questionnaire (VFQ-25) composite score. The VFQ-25 is a patient-reported outcome instrument assessing vision-related quality of life and consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs plus an additional single-item general health rating question. Each item was converted to a 0-100 scale for scoring, where 100 represents the best possible score on the measure and 0 represents the worst. Items within each subscale were averaged to create 12 subscale scores (11 subscales related to vision + 1 subscale related to general health). The vision-related subscale scores (excluding the general health rating question) were then averaged to calculate the composite score.
Outcome measures
| Measure |
GS010-GS010
n=39 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=36 Participants
All study participants received single IVT injection of GS010 in their first-affected eye (droplet digital polymerase chain reaction \[ddPCR\] dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Quality of Life Questionnaire: VFQ-25 - Composite Score
|
11.8 Points
Standard Error 2.48
|
15.0 Points
Standard Error 2.51
|
Adverse Events
GS010-GS010
Serious events: 5 serious events
Other events: 49 other events
Deaths: 0 deaths
GS010-Placebo
Serious events: 6 serious events
Other events: 49 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
GS010-GS010
n=49 participants at risk
All study participants received single IVT injection of GS010 in their first-affected eye (ddPCR dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=49 participants at risk
All study participants received single IVT injection of GS010 in their first-affected eye (ddPCR dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis (Systemic)
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
General disorders
Death (Systemic)
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
General disorders
Sudden cardiac death (Systemic)
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Infections and infestations
Appendicitis (Systemic)
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Infections and infestations
Clostridium difficile infection (Systemic)
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage (Systemic)
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia (Systemic)
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms (Systemic)
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Nervous system disorders
Multiple sclerosis (Systemic)
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Psychiatric disorders
Psychotic disorder (Systemic)
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure (Systemic)
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
Other adverse events
| Measure |
GS010-GS010
n=49 participants at risk
All study participants received single IVT injection of GS010 in their first-affected eye (ddPCR dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received a single IVT injection of GS010 in their second-affected/not-yet-affected eye at a ddPCR dose of 1.2/1.3E11 vg in 90 μL.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
GS010-Placebo
n=49 participants at risk
All study participants received single IVT injection of GS010 in their first-affected eye (ddPCR dose of 1.2/1.3E11 vg in 90 μL). Participants randomized to this treatment arm received placebo IVT injection (volume of 90 μL) in their second-affected/not-yet-affected eye.
Treatment could be performed either on a single day (1 IVT injection in each eye on Day 0) or on 2 consecutive days (1st IVT injection on Day -1 and 2nd IVT injection on Day 0).
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia (First-Affected Eye)
|
8.2%
4/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Conjunctival hyperaemia (Second-affected/not-Yet-Affected Eye)
|
8.2%
4/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Dry Eye (First-Affected Eye)
|
6.1%
3/49 • Number of events 3 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
8.2%
4/49 • Number of events 4 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Dry eye (Second-affected/not-Yet-Affected Eye)
|
6.1%
3/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
10.2%
5/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Eye pain (First-Affected Eye)
|
12.2%
6/49 • Number of events 6 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
12.2%
6/49 • Number of events 6 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Eye pain (Second-affected/not-Yet-Affected Eye)
|
18.4%
9/49 • Number of events 9 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
6.1%
3/49 • Number of events 3 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Intraocular pressure increased (First-Affected Eye)
|
16.3%
8/49 • Number of events 9 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
12.2%
6/49 • Number of events 7 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Intraocular pressure increased (Second-affected/not-Yet-Affected Eye)
|
18.4%
9/49 • Number of events 9 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 3 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Iridocyclitis (First-Affected Eye)
|
24.5%
12/49 • Number of events 17 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
22.4%
11/49 • Number of events 12 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Iridocyclitis (Second-affected/not-Yet-Affected Eye)
|
28.6%
14/49 • Number of events 20 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
4.1%
2/49 • Number of events 2 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Iritis (First-Affected Eye)
|
14.3%
7/49 • Number of events 8 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
22.4%
11/49 • Number of events 14 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Iritis (Second-affected/not-Yet-Affected Eye)
|
10.2%
5/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Keratic precipitates (First-Affected Eye)
|
28.6%
14/49 • Number of events 16 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
28.6%
14/49 • Number of events 17 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Keratic precipitates (Second-affected/not-Yet-Affected Eye)
|
28.6%
14/49 • Number of events 15 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Punctate keratitis (First-Affected Eye)
|
20.4%
10/49 • Number of events 12 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
14.3%
7/49 • Number of events 11 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Punctate keratitis (Second-affected/not-Yet-Affected Eye)
|
12.2%
6/49 • Number of events 6 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
10.2%
5/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Uveitis (First-Affected Eye)
|
20.4%
10/49 • Number of events 10 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
12.2%
6/49 • Number of events 7 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Uveitis (Second-affected/not-Yet-Affected Eye)
|
18.4%
9/49 • Number of events 10 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
0.00%
0/49 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Vitreous floaters (First-Affected Eye)
|
8.2%
4/49 • Number of events 4 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
12.2%
6/49 • Number of events 6 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Vitreous floaters (Second-affected/not-Yet-Affected Eye)
|
10.2%
5/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
6.1%
3/49 • Number of events 4 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Vitritis (First-Affected Eye)
|
34.7%
17/49 • Number of events 21 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
44.9%
22/49 • Number of events 24 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Eye disorders
Vitritis (Second-affected/not-Yet-Affected Eye)
|
34.7%
17/49 • Number of events 19 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
4.1%
2/49 • Number of events 2 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Infections and infestations
COVID-19 (Systemic)
|
4.1%
2/49 • Number of events 2 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
10.2%
5/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Infections and infestations
Influenza (Systemic)
|
4.1%
2/49 • Number of events 2 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
6.1%
3/49 • Number of events 3 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Infections and infestations
Nasopharyngitis (Systemic)
|
6.1%
3/49 • Number of events 3 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
18.4%
9/49 • Number of events 11 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Investigations
Blood glucose increased (Systemic)
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
8.2%
4/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Investigations
Gamma glutamyltransferase increased (Systemic)
|
2.0%
1/49 • Number of events 1 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
10.2%
5/49 • Number of events 5 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Nervous system disorders
Headache (Systemic)
|
22.4%
11/49 • Number of events 13 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
16.3%
8/49 • Number of events 8 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Psychiatric disorders
Anxiety (Systemic)
|
6.1%
3/49 • Number of events 3 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
4.1%
2/49 • Number of events 2 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
|
Psychiatric disorders
Insomnia (Systemic)
|
6.1%
3/49 • Number of events 3 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
6.1%
3/49 • Number of events 4 • From the time of the ICF was signed throughout the completion of the study follow-up (Year 5)
Patients from the safety population were classified according to the study treatment actually received, leading to 49 patients in each treatment arm (1 patient randomized to GS010-Placebo had received the study treatment for GS010-GS010). Systemic adverse events are reported per participant based on total treatment exposure. Ocular adverse events are reported per participant but identified by the specific eye of occurrence.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place