Trial Outcomes & Findings for Study of RS1 Ocular Gene Transfer for X-linked Retinoschisis (NCT NCT02317887)
NCT ID: NCT02317887
Last Updated: 2025-02-14
Results Overview
Includes a) substantial functional change (change \>=10 electronic visual acuity letters in best-corrected visual acuity from average of baseline visits), b) decrease in electroretinogram response amplitude (\>=75% from average of baseline visits), c) severe ocular inflammation beyond inflammation anticipated consequent to an intravitreal injection; d) adverse events deemed clinically-related to the intraocular administration technique, and e) abnormal laboratory findings beyond Grade 1 Common Terminology Criteria for Adverse Events v5.0 and/or clinically significantly different than baseline. a)-d) only includes events occurring in the study eye.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 0 through Year 2, inclusive
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
Cohort 1
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
2
|
1
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
2
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Eyes
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=6 Eyes
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=6 Eyes
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=4 Eyes
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=2 Eyes
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Total
n=24 Eyes
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
0 Participants
|
11 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
|
1 Participants
n=12 Participants
|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 11.5 • n=3 Participants
|
47.7 years
STANDARD_DEVIATION 11.9 • n=3 Participants
|
36.3 years
STANDARD_DEVIATION 12.2 • n=3 Participants
|
41.0 years
STANDARD_DEVIATION 5.7 • n=2 Participants
|
38.0 years
n=1 Participants
|
—
|
45.7 years
STANDARD_DEVIATION 12.7 • n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
—
|
12 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
—
|
2 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
10 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
—
|
12 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
—
|
12 Participants
n=12 Participants
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Rod Amplitude: Study Eye
|
51.5 µv
STANDARD_DEVIATION 40.7 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
64.7 µv
STANDARD_DEVIATION 34.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
57.2 µv
STANDARD_DEVIATION 8.7 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
75.0 µv
STANDARD_DEVIATION 25.5 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
130.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
66.7 µv
STANDARD_DEVIATION 32.5 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Rod Amplitude: Fellow Eye
|
73.8 µv
STANDARD_DEVIATION 50.2 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
46.3 µv
STANDARD_DEVIATION 4.8 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
70.3 µv
STANDARD_DEVIATION 31.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
73.8 µv
STANDARD_DEVIATION 14.5 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
149.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
72.4 µv
STANDARD_DEVIATION 37.3 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 0dB Amplitude: Study Eye
|
166.8 µv
STANDARD_DEVIATION 38.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
222.5 µv
STANDARD_DEVIATION 48.0 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
201.3 µv
STANDARD_DEVIATION 17.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
162.5 µv
STANDARD_DEVIATION 8.5 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
211.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
192.4 µv
STANDARD_DEVIATION 37.3 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 0dB Amplitude: Fellow Eye
|
180.2 µv
STANDARD_DEVIATION 60.8 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
176.5 µv
STANDARD_DEVIATION 75.8 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
190.5 µv
STANDARD_DEVIATION 21.9 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
186.8 µv
STANDARD_DEVIATION 23.7 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
235 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
187.5 µv
STANDARD_DEVIATION 45.9 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 0dB Amplitude: Study Eye
|
122.5 µv
STANDARD_DEVIATION 60.7 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
175.2 µv
STANDARD_DEVIATION 22.8 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
142.5 µv
STANDARD_DEVIATION 17.1 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
125.8 µv
STANDARD_DEVIATION 34.3 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
243.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
151.3 µv
STANDARD_DEVIATION 47.0 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 0dB Amplitude: Fellow Eye
|
138.2 µv
STANDARD_DEVIATION 66.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
134.3 µv
STANDARD_DEVIATION 21.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
138.2 µv
STANDARD_DEVIATION 24.8 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
137.25 µv
STANDARD_DEVIATION 42.1 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
294 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
150.0 µv
STANDARD_DEVIATION 56.8 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 11dB Amplitude: Study Eye
|
260.0 µv
STANDARD_DEVIATION 46.8 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
298.5 µv
STANDARD_DEVIATION 57.0 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
297.0 µv
STANDARD_DEVIATION 17.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
258.3 µv
STANDARD_DEVIATION 34.3 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
272.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
279.6 µv
STANDARD_DEVIATION 39.0 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 11dB Amplitude: Fellow Eye
|
276.2 µv
STANDARD_DEVIATION 89.0 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
244.8 µv
STANDARD_DEVIATION 96.2 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
259.5 µv
STANDARD_DEVIATION 15.1 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
269.8 µv
STANDARD_DEVIATION 64.0 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
301.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
265.2 µv
STANDARD_DEVIATION 61.8 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 11dB Amplitude: Study Eye
|
175.0 µv
STANDARD_DEVIATION 67.2 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
202.5 µv
STANDARD_DEVIATION 19.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
193.3 µv
STANDARD_DEVIATION 10.9 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
175.0 µv
STANDARD_DEVIATION 62.2 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
288.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
195.9 µv
STANDARD_DEVIATION 47.4 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 11dB Amplitude: Fellow Eye
|
197.8 µv
STANDARD_DEVIATION 73.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
171.5 µv
STANDARD_DEVIATION 15.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
184.3 µv
STANDARD_DEVIATION 23.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
184.8 µv
STANDARD_DEVIATION 64.0 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
313.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
195.3 µv
STANDARD_DEVIATION 54.4 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Oscillatory Potentials Amplitude: Study Eye
|
13.8 µv
STANDARD_DEVIATION 7.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
25.2 µv
STANDARD_DEVIATION 11.0 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
19.3 µv
STANDARD_DEVIATION 12.4 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
23.3 µv
STANDARD_DEVIATION 15.2 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
46.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
22.3 µv
STANDARD_DEVIATION 12.5 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Dark-Adapted Oscillatory Potentials Amplitude: Fellow Eye
|
13.7 µv
STANDARD_DEVIATION 5.4 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
19.5 µv
STANDARD_DEVIATION 5.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
22.2 µv
STANDARD_DEVIATION 18.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
26.5 µv
STANDARD_DEVIATION 20.5 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
61.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
23.4 µv
STANDARD_DEVIATION 16.6 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Light-Adapted Cone B-Wave 0dB Amplitude: Study Eye
|
39.3 µv
STANDARD_DEVIATION 23.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
66.2 µv
STANDARD_DEVIATION 22.8 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
60.7 µv
STANDARD_DEVIATION 14.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
62.5 µv
STANDARD_DEVIATION 41.0 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
97.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
60.1 µv
STANDARD_DEVIATION 25.4 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Light-Adapted Cone B-Wave 0dB Amplitude: Fellow Eye
|
46.8 µv
STANDARD_DEVIATION 22.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
57.8 µv
STANDARD_DEVIATION 13.7 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
66.3 µv
STANDARD_DEVIATION 23.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
75.0 µv
STANDARD_DEVIATION 48.8 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
106.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
64.1 µv
STANDARD_DEVIATION 26.8 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Light-Adapted Cone A-Wave 11dB Amplitude: Study Eye
|
57.2 µv
STANDARD_DEVIATION 10.1 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
75.5 µv
STANDARD_DEVIATION 13.7 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
76.5 µv
STANDARD_DEVIATION 8.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
68.5 µv
STANDARD_DEVIATION 14.1 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
66.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
69.3 µv
STANDARD_DEVIATION 12.2 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Light-Adapted Cone A-Wave 11dB Amplitude: Fellow Eye
|
59.2 µv
STANDARD_DEVIATION 23.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
66.5 µv
STANDARD_DEVIATION 9.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
70.7 µv
STANDARD_DEVIATION 23.9 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
65.5 µv
STANDARD_DEVIATION 24.7 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
63.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
65.3 µv
STANDARD_DEVIATION 17.2 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Light-Adapted Flicker Amplitude: Study Eye
|
33.8 µv
STANDARD_DEVIATION 15.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
55.8 µv
STANDARD_DEVIATION 25.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
46.2 µv
STANDARD_DEVIATION 11.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
55.8 µv
STANDARD_DEVIATION 25.8 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
76.0 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
49.6 µv
STANDARD_DEVIATION 19.9 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Electroretinography Combined Response Amplitudes
Light-Adapted Flicker Amplitude: Fellow Eye
|
37.5 µv
STANDARD_DEVIATION 12.1 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
47.8 µv
STANDARD_DEVIATION 13.3 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
52.7 µv
STANDARD_DEVIATION 26.6 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
63.0 µv
STANDARD_DEVIATION 38.2 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
82.5 µv
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
51.9 µv
STANDARD_DEVIATION 22.1 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Best Corrected Visual Acuity
Study Eye
|
43.7 letters read
STANDARD_DEVIATION 8.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
45.8 letters read
STANDARD_DEVIATION 16.5 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
48.7 letters read
STANDARD_DEVIATION 8.4 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
52.0 letters read
STANDARD_DEVIATION 2.8 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
61.0 letters read
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
48.3 letters read
STANDARD_DEVIATION 10.0 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
|
Best Corrected Visual Acuity
Fellow Eye
|
51.8 letters read
STANDARD_DEVIATION 4.9 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
59.5 letters read
STANDARD_DEVIATION 6.9 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
66.2 letters read
STANDARD_DEVIATION 4.1 • n=3 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
66.3 letters read
STANDARD_DEVIATION 8.8 • n=2 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
68.0 letters read
n=1 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
—
|
61.1 letters read
STANDARD_DEVIATION 8.0 • n=12 Eyes • Each individual measure summarizes data at the eye-level (either Study Eye or Fellow Eye) as indicated in the description of the measure itself.
|
PRIMARY outcome
Timeframe: Day 0 through Year 2, inclusivePopulation: Includes all participants enrolled in the study and were administered the AAV vector injection, regardless of follow-up.
Includes a) substantial functional change (change \>=10 electronic visual acuity letters in best-corrected visual acuity from average of baseline visits), b) decrease in electroretinogram response amplitude (\>=75% from average of baseline visits), c) severe ocular inflammation beyond inflammation anticipated consequent to an intravitreal injection; d) adverse events deemed clinically-related to the intraocular administration technique, and e) abnormal laboratory findings beyond Grade 1 Common Terminology Criteria for Adverse Events v5.0 and/or clinically significantly different than baseline. a)-d) only includes events occurring in the study eye.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=3 Participants
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=3 Participants
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=2 Participants
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=1 Participants
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Adverse Events (AEs) Affecting Ocular Function That Differ Clinically From Those Expected in the Normal Course of Progression of XLRS
AEs affecting ocular function (differ clinically from expected in normal progression of XLRS)
|
3 events
|
3 events
|
12 events
|
6 events
|
30 events
|
—
|
|
Adverse Events (AEs) Affecting Ocular Function That Differ Clinically From Those Expected in the Normal Course of Progression of XLRS
Substantial functional change (Day 0-Year 2)
|
0 events
|
0 events
|
3 events
|
0 events
|
21 events
|
—
|
|
Adverse Events (AEs) Affecting Ocular Function That Differ Clinically From Those Expected in the Normal Course of Progression of XLRS
Decrease in Electroretinogram Response Amplitude (Day 0-Year 2)
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
—
|
|
Adverse Events (AEs) Affecting Ocular Function That Differ Clinically From Those Expected in the Normal Course of Progression of XLRS
Severe Ocular Inflammation (Day 8-Year 2)
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
—
|
|
Adverse Events (AEs) Affecting Ocular Function That Differ Clinically From Those Expected in the Normal Course of Progression of XLRS
AEs Clinically Related to Intraocular Administration Technique (Day 8-Year 2)
|
0 events
|
2 events
|
8 events
|
2 events
|
9 events
|
—
|
|
Adverse Events (AEs) Affecting Ocular Function That Differ Clinically From Those Expected in the Normal Course of Progression of XLRS
Abnormal Laboratory Findings (Day 0-Year 2)
|
3 events
|
1 events
|
1 events
|
4 events
|
0 events
|
—
|
SECONDARY outcome
Timeframe: Baseline 1 through Year 2Population: Includes all participants enrolled in the study and were administered the AAV vector injection, regardless of follow-up with data available for at least one baseline visit and at Year 2.
Change in electroretinography combined response amplitudes from average of baseline 1 and 2 measurements. The higher the amplitude, the better.
Outcome measures
| Measure |
Cohort 1
n=6 Eyes
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=6 Eyes
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=3 Participants
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=1 Participants
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=1 Participants
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Rod Amplitude: Study Eye
|
13.8 µV
Standard Deviation 19.3
|
-21.7 µV
Standard Deviation 13.5
|
-13.8 µV
Standard Deviation 16.2
|
-19.0 µV
|
-11.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Rod Amplitude: Fellow Eye
|
-8.5 µV
Standard Deviation 25.5
|
14.0 µV
Standard Deviation 45.2
|
-14.0 µV
Standard Deviation 38.5
|
4.5 µV
|
14.5 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 0dB Amplitude: Study Eye
|
-0.5 µV
Standard Deviation 40.3
|
-45.5 µV
Standard Deviation 19.5
|
-21.7 µV
Standard Deviation 23.0
|
15.5 µV
|
-15.5 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 0dB Amplitude: Fellow Eye
|
-20.8 µV
Standard Deviation 10.4
|
-21.8 µV
Standard Deviation 19.5
|
-7.5 µV
Standard Deviation 6.8
|
4.5 µV
|
-2.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 0dB Amplitude: Study Eye
|
-11.5 µV
Standard Deviation 24.5
|
-44.8 µV
Standard Deviation 22.0
|
-9.5 µV
Standard Deviation 20.0
|
23.0 µV
|
-43.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 0dB Amplitude: Fellow Eye
|
-17.5 µV
Standard Deviation 31.4
|
-26.0 µV
Standard Deviation 21.8
|
-6.8 µV
Standard Deviation 28.4
|
14.0 µV
|
-39.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 11dB Amplitude: Study Eye
|
1.3 µV
Standard Deviation 34.1
|
-29.5 µV
Standard Deviation 24.3
|
-30.7 µV
Standard Deviation 36.3
|
-36.5 µV
|
-4.5 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone A-Wave 11dB Amplitude: Fellow Eye
|
-36.8 µV
Standard Deviation 25.0
|
-8.5 µV
Standard Deviation 8.0
|
-3.2 µV
Standard Deviation 18.0
|
-23.0 µV
|
-12.5 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 11dB Amplitude: Study Eye
|
-5.0 µV
Standard Deviation 34.2
|
-26.5 µV
Standard Deviation 24.9
|
-15.7 µV
Standard Deviation 16.5
|
-8.0 µV
|
-35.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Combined Rod-Cone B-Wave 11dB Amplitude: Fellow Eye
|
-17.5 µV
Standard Deviation 27.4
|
-18.8 µV
Standard Deviation 20.9
|
-15.3 µV
Standard Deviation 11.1
|
10.0 µV
|
-8.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Oscillatory Potentials Amplitude: Study Eye
|
-3.5 µV
Standard Deviation 2.2
|
-12.2 µV
Standard Deviation 11.6
|
-4.7 µV
Standard Deviation 9.4
|
-5.0 µV
|
-8.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Dark-Adapted Oscillatory Potentials Amplitude: Fellow Eye
|
-0.3 µV
Standard Deviation 3.8
|
-6.8 µV
Standard Deviation 4.8
|
-3.8 µV
Standard Deviation 9.5
|
-9.0 µV
|
-10.5 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Light-Adapted Cone B-Wave 0dB Amplitude: Study Eye
|
-4.7 µV
Standard Deviation 6.3
|
-4.8 µV
Standard Deviation 8.0
|
-2.0 µV
Standard Deviation 13.9
|
12.5 µV
|
-0.5 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Light-Adapted Cone B-Wave 0dB Amplitude: Fellow Eye
|
-4.8 µV
Standard Deviation 6.7
|
-4.2 µV
Standard Deviation 2.4
|
3.3 µV
Standard Deviation 25.9
|
-5.5 µV
|
9.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Light-Adapted Cone A-Wave 11dB Amplitude: Study Eye
|
1.8 µV
Standard Deviation 12.7
|
1.5 µV
Standard Deviation 18.2
|
-5.5 µV
Standard Deviation 13.0
|
-10.5 µV
|
-2.5 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Light-Adapted Cone A-Wave 11dB Amplitude: Fellow Eye
|
-6.8 µV
Standard Deviation 2.4
|
-6.2 µV
Standard Deviation 3.8
|
-1.0 µV
Standard Deviation 14.1
|
-7.0 µV
|
7.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Light-Adapted Flicker Amplitude: Study Eye
|
-4.5 µV
Standard Deviation 11.5
|
-10.2 µV
Standard Deviation 16.8
|
1.2 µV
Standard Deviation 12.8
|
-24.0 µV
|
-20.0 µV
|
—
|
|
Change in Electroretinography Combined Response Amplitudes
Light-Adapted Flicker Amplitude: Fellow Eye
|
-0.2 µV
Standard Deviation 5.3
|
-1.8 µV
Standard Deviation 11.5
|
3.3 µV
Standard Deviation 22.4
|
-22.0 µV
|
2.5 µV
|
—
|
SECONDARY outcome
Timeframe: Baseline 1 through Year 2Population: Includes all participants enrolled in the study and were administered the AAV vector injection, regardless of follow-up with data available for at least one baseline visit and at Year 2.
Mean change in best corrected visual acuity (BCVA) at Year 2 compared to average of baseline 1 and 2. BCVA is measured via Electronic Visual Acuity (EVA).
Outcome measures
| Measure |
Cohort 1
n=6 Eyes
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=6 Eyes
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=6 Eyes
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=2 Eyes
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=2 Eyes
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Mean Change in Best Corrected Visual Acuity
Study Eye
|
2.7 letters read
Standard Deviation 3.6
|
-0.2 letters read
Standard Deviation 1.2
|
-2.7 letters read
Standard Deviation 2.5
|
-1.0 letters read
|
-23.0 letters read
|
—
|
|
Mean Change in Best Corrected Visual Acuity
Fellow Eye
|
-0.2 letters read
Standard Deviation 2.8
|
0.5 letters read
Standard Deviation 3.8
|
-0.2 letters read
Standard Deviation 7.6
|
-1.5 letters read
|
-26.0 letters read
|
—
|
SECONDARY outcome
Timeframe: Baseline 1 through Year 2Population: Includes all participants enrolled in the study and were administered the AAV vector injection, regardless of follow-up with data available for at least one baseline visit and at Year 2.
Median and distribution of change in best-corrected visual acuity (BCVA) at Year 2 compared to average of baseline 1 and 2. BCVA is measured via Electronic Visual Acuity (EVA).
Outcome measures
| Measure |
Cohort 1
n=6 Eyes
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=6 Eyes
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=6 Eyes
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=2 Eyes
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=2 Eyes
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Median and Distribution of Change in Best-Corrected Visual Acuity
Study Eye
|
4.5 letters read
Interval -2.0 to 5.0
|
0.5 letters read
Interval -2.0 to 1.0
|
-3.0 letters read
Interval -5.0 to 0.0
|
-1.0 letters read
|
-23.0 letters read
|
—
|
|
Median and Distribution of Change in Best-Corrected Visual Acuity
Fellow Eye
|
-1.0 letters read
Interval -3.0 to 3.0
|
1.0 letters read
Interval -4.0 to 4.0
|
-1.5 letters read
Interval -7.0 to 8.0
|
-1.5 letters read
|
-26.0 letters read
|
—
|
SECONDARY outcome
Timeframe: Day 0 through end of study participation (Year 5 or Year 7)Population: Includes all participants enrolled in the study and were administered the AAV vector injection, regardless of follow-up.
Formation of circulating systemic anti-AAV or anti-RS1 antibodies assessed via serologic testing
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=3 Participants
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=3 Participants
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=2 Participants
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=1 Participants
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Formation of Circulating Systemic Anti-AAV or Anti-RS1 Antibodies
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
—
|
SECONDARY outcome
Timeframe: Baseline 1 through end of study participation (Year 5 or Year 7)Population: Outcome was a secondary outcome. Images were not graded by a Reading Center and therefore data were not collected. Therefore these analyses were not performed.
Change in retinal structure as measured by optical coherence tomography (OCT) compared to average of baseline 1 and 2. Includes a) quantitative measures of total retinal thickness obtained with the Cirrus OCT using macular cube scans, b) qualitative morphologic changes to macula anatomy investigated using the tracking ability of the Heidelberg Spectralis OCT system and c) length of intact ellipsoid zone on the OCT and any findings of restoration of this reflectivity line.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline 1 through end of study participation (Year 5 or Year 7)Population: Outcome was a secondary outcome. Images were not graded by a Reading Center and therefore data were not collected. Therefore these analyses were not performed.
Change in central visual field sensitivity as measured by microperimetry (MP-1) Visual Field testing compared to average of baseline 1 and 2. Includes mean sensitivities, number of scotomatous points and number of points with a significant change in sensitivity.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=3 participants at risk
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=3 participants at risk
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=2 participants at risk
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=1 participants at risk
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
1e9 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 2
n=3 participants at risk
1e10 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 3
n=3 participants at risk
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 4
n=2 participants at risk
1e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 5
n=1 participants at risk
3e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
Cohort 6
Not to exceed 6e11 vg/eye
RS1 AAV Vector: Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
Bilirubin urine present
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
Blood cholesterol increased
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
Glucose urine present
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
Lipids increased
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Investigations
White blood cells urine positive
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Psychiatric disorders
Stress
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
66.7%
2/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Vascular disorders
Orthostatic hypotension
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
2/2 • Number of events 3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
66.7%
2/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
66.7%
2/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Strabismus
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Retinal tear
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Uveitic glaucoma
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Visual acuity reduced
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Vitritis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Conjunctivitis
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Conjunctivitis bacterial
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Cardiac disorders
Myocardial ischaemia
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Abnormal sensation in eye
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Anterior chamber inflammation
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
66.7%
2/3 • Number of events 4 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Central serous chorioretinopathy
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Eye irritation
|
33.3%
1/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Halo vision
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Keratic precipitates
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Lacrimal gland enlargement
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
33.3%
1/3 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
66.7%
2/3 • Number of events 2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
50.0%
1/2 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
|
Eye disorders
Retinal vasculitis
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/3 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
0.00%
0/2 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
100.0%
1/1 • Number of events 1 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
—
0/0 • Day 0 to end of study participation (Year 5 or Year 7)
All enrolled participants are at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place