Trial Outcomes & Findings for Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS) (NCT NCT02416622)
NCT ID: NCT02416622
Last Updated: 2023-06-12
Results Overview
Number of participants with ocular adverse events, assessed by standard ophthalmic examination, including slit lamp biomicroscopy, tonometry, and indirect ophthalmoscopy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
From Day 0 to Month 12 (12 months)
Results posted on
2023-06-12
Participant Flow
No participants have completed the study at this time because the study is ongoing (overall status: active, not recruiting). All enrolled participants are in long term follow-up.
Participant milestones
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
13
|
|
Overall Study
Completed Month 12
|
6
|
8
|
13
|
|
Overall Study
Started Long-Term Follow-Up
|
6
|
8
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS)
Baseline characteristics by cohort
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
n=6 Participants
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
n=8 Participants
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
n=13 Participants
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Month 12 (12 months)Population: All treated study participants with ocular treatment-emergent adverse events (TEAEs).
Number of participants with ocular adverse events, assessed by standard ophthalmic examination, including slit lamp biomicroscopy, tonometry, and indirect ophthalmoscopy.
Outcome measures
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
n=6 Participants
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
n=8 Participants
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
n=13 Participants
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events
|
6 Participants
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 12 (12 Months)Population: All treated study participants with available data.
Change in ETDRS (Early Treatment of Diabetic Retinopathy) Letter Score. Minimum value=0; Maximum value=100. Higher scores indicate better visual acuity. Change = 12 Mo value - Baseline value
Outcome measures
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
n=6 Participants
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
n=8 Participants
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
n=12 Participants
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Baseline Letter Score (Study Eye)
|
38.7 ETDRS Letter Score
Standard Deviation 16.82
|
56.3 ETDRS Letter Score
Standard Deviation 8.65
|
50.4 ETDRS Letter Score
Standard Deviation 18.93
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Month 12 Letter Score (Study Eye)
|
39.5 ETDRS Letter Score
Standard Deviation 16.65
|
59.9 ETDRS Letter Score
Standard Deviation 10.29
|
51.4 ETDRS Letter Score
Standard Deviation 18.28
|
SECONDARY outcome
Timeframe: From Day 0 to Month 12 (12 months)Population: All treated study participants with available data.
Change in cystic cavity volume (mm\^3), obtained from spectral domain optical coherence tomography (SD-OCT) of the retina, yielding volumetric measures of schisis cavity size and total cyst cavity. Change = 12 Mo value - Baseline value
Outcome measures
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
n=6 Participants
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
n=7 Participants
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
n=10 Participants
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
|---|---|---|---|
|
Change From Baseline in Schisis Cavity Size on Optical Coherence Tomography (OCT)
Baseline Cystic Cavity Volume (mm^3) (Study Eye)
|
1.13 Cystic Cavity Volume (mm^3)
Standard Deviation 1.34
|
1.12 Cystic Cavity Volume (mm^3)
Standard Deviation 0.68
|
1.28 Cystic Cavity Volume (mm^3)
Standard Deviation 1.57
|
|
Change From Baseline in Schisis Cavity Size on Optical Coherence Tomography (OCT)
Month12 Cystic Cavity Volume (mm^3) (Study Eye)
|
1.33 Cystic Cavity Volume (mm^3)
Standard Deviation 1.82
|
1.28 Cystic Cavity Volume (mm^3)
Standard Deviation 0.62
|
1.04 Cystic Cavity Volume (mm^3)
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: From Day 0 to Month 12 (12 months)Population: All treated study participants with available data.
Change in dark-adapted 3.0 B-wave amplitude (μV). Change = 12 Mo value - Baseline value
Outcome measures
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
n=6 Participants
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
n=6 Participants
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
n=10 Participants
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
|---|---|---|---|
|
Change From Baseline in B-wave Amplitude in Electroretinogram (ERG) Responses
Baseline Dark Adapted 3.0 B-Wave Amplitude (μV)
|
107.3 μV
Standard Deviation 50.09
|
206.0 μV
Standard Deviation 60.95
|
169.9 μV
Standard Deviation 62.82
|
|
Change From Baseline in B-wave Amplitude in Electroretinogram (ERG) Responses
M12 Dark Adapted 3.0 B-Wave Amplitude (μV)
|
92.8 μV
Standard Deviation 61.94
|
142.2 μV
Standard Deviation 62.77
|
164.0 μV
Standard Deviation 53.11
|
Adverse Events
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
n=6 participants at risk
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
n=8 participants at risk
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
n=13 participants at risk
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Cardiac disorders
Atrial Fibrillation
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Gastrointestinal disorders
Faecaloma
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Nervous system disorders
Cerebellar stroke
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
Other adverse events
| Measure |
rAAV2tYF-CB-hRS1 1 x 10^11 vg Per Eye
n=6 participants at risk
Group 1A/1B: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 1 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 3 x 10^11 vg Per Eye
n=8 participants at risk
Group 2/2A: Adult and pediatric participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 3 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
rAAV2tYF-CB-hRS1 6 x 10^11 vg Per Eye
n=13 participants at risk
Group 3/4: Adult participants were administered a single intravitreal (IVT) injection of rAAV2tYF-CB-hRS1, once in the study eye, at a dose of 6 x 10\^11 vg/eye and followed for a minimum of 12 months after dose administration.
|
|---|---|---|---|
|
Eye disorders
Keratic precipitates
|
33.3%
2/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
53.8%
7/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Vitritis
|
50.0%
3/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
37.5%
3/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
38.5%
5/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Anterior chamber cells
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
61.5%
8/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
46.2%
6/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Eye pain
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
30.8%
4/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Vitreal cells
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
38.5%
5/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Conjunctival haemorrhage
|
33.3%
2/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
30.8%
4/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Vitreous haze
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
30.8%
4/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Anterior chamber inflammation
|
33.3%
2/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Retinal tear
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Conjunctival hyperaemia
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Photopsia
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Eyelid ptosis
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
General disorders
Injection site haemorrhage
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
25.0%
2/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
General disorders
Injection site discomfort
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Investigations
Intraocular pressure
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
General disorders
Feeling hot
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Investigations
Weight increased
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Infections and infestations
Viral upper respiratory tract infection
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
37.5%
3/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
30.8%
4/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
30.8%
4/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Metabolism and nutrition disorders
Increased appetite
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
7.7%
1/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
0.00%
0/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
15.4%
2/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
12.5%
1/8 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
23.1%
3/13 • Study Day 0 through Month 12- Adverse Events; Study ongoing: adverse events beyond Month 12 to be updated at a later date
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60