A Phase 2 interventional study of ADX-2191 and ADX-2191 in Retinitis Pigmentosa, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 2, Interventional, and Treatment
An open-label Phase II clinical trial, 8 (eight) subjects with retinitis pigmentosa due to rhodopsin mutations (including P23H) will be identified and treated with serial intravitreal injections of ADX-2191 in the worse seeing eye. Ocular structure and function will be evaluated.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's enrollment of 8 is below the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Aldeyra Therapeutics, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 25 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: ADX-2191
Drug: ADX-2191
Number of Subjects With Serious Adverse Events
The proportion of subjects that experience at least one serious adverse event
Time frame: The safety assessment period was 16 weeks.
| Milestone | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing |
|---|---|---|
| Started | 4 | 4 |
| Completed | 4 | 4 |
| Not completed | 0 | 0 |
The proportion of subjects that experience at least one serious adverse event
| Participants | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing |
|---|---|---|
| Number of Subjects With Serious Adverse Events | 0 | 0 |
Collected over The safety assessment period was 16 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADX-2191 Monthly Dosing | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| ADX-2191 Twice-monthly Dosing | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Event | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing |
|---|---|---|
| General disorders and administration site conditionsGeneral disorders | 3/4 | 3/4 |
Safety population
| Age, Categorical(Participants) | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 2 | 1 | 3 |
| Sex: Female, Male(Participants) | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 3 | 7 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 4 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | ADX-2191 Monthly Dosing | ADX-2191 Twice-monthly Dosing | Total |
|---|---|---|---|
| United States | 4 | 4 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2022 to primary completion in Jun 2023, 11 months.
Results were first posted in Apr 2026, 2 years 10 months after primary completion. A results delay was requested in Apr 2024.
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Studies of the drug tested here: Methotrexate