Phase 2
N=8
A Study in Subjects With Retinitis Pigmentosa
Retinitis Pigmentosa
Bottom Line
View on ClinicalTrials.gov: NCT05392179 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Number of Subjects With Serious Adverse Events — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ADX-2191 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious Adverse Events |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Up to 8 adult patients age 18 or older
- Diagnosis of retinitis pigmentosa due to rhodopsin gene mutation, including P23H
- Impairment on Visual Field as determined by perimetry
Exclusion Criteria
- Age < 18 years
- Pregnant
- Previous inflammatory/infectious events involving the eyes
Data sourced from ClinicalTrials.gov (NCT05392179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.