Trial Outcomes & Findings for A Study in Subjects With Retinitis Pigmentosa (NCT NCT05392179)
NCT ID: NCT05392179
Last Updated: 2026-04-23
Results Overview
The proportion of subjects that experience at least one serious adverse event
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
The safety assessment period was 16 weeks.
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
ADX-2191 Monthly Dosing
Monthly intravitreal injections of ADX-2191 for a total of three injections
|
ADX-2191 Twice-monthly Dosing
Twice-monthly intravitreal injections of ADX-2191 for a total of six injections
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Subjects With Retinitis Pigmentosa
Baseline characteristics by cohort
| Measure |
ADX-2191 Monthly Dosing
n=4 Participants
Monthly intravitreal injections of ADX-2191 for a total of three injections
|
ADX-2191 Twice-monthly Dosing
n=4 Participants
Twice-monthly intravitreal injections of ADX-2191 for a total of six injections
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=60 Participants
|
3 Participants
n=56 Participants
|
5 Participants
n=116 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=60 Participants
|
3 Participants
n=56 Participants
|
5 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=60 Participants
|
3 Participants
n=56 Participants
|
7 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
8 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
8 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: The safety assessment period was 16 weeks.Population: Safety population
The proportion of subjects that experience at least one serious adverse event
Outcome measures
| Measure |
ADX-2191 Monthly Dosing
n=4 Participants
Monthly intravitreal injections of ADX-2191 for a total of three injections
|
ADX-2191 Twice-monthly Dosing
n=4 Participants
Twice-monthly intravitreal injections of ADX-2191 for a total of six injections
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
ADX-2191 Monthly Dosing
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ADX-2191 Twice-monthly Dosing
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADX-2191 Monthly Dosing
n=4 participants at risk
Monthly intravitreal injections of ADX-2191 for a total of three injections
|
ADX-2191 Twice-monthly Dosing
n=4 participants at risk
Twice-monthly intravitreal injections of ADX-2191 for a total of six injections
|
|---|---|---|
|
General disorders
General disorders and administration site conditions
|
75.0%
3/4 • Number of events 7 • The safety assessment period was 16 weeks.
|
75.0%
3/4 • Number of events 3 • The safety assessment period was 16 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place