A Study in Subjects With Retinitis Pigmentosa

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Retinitis Pigmentosa

Treatments: Drug: ADX-2191

Study type: Interventional

Funder types: Industry

Identifiers

NCT05392179

ADX-2191-RP-001

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Up to 8 adult patients age 18 or older
2. Diagnosis of retinitis pigmentosa due to rhodopsin gene mutation, including P23H
3. Impairment on Visual Field as determined by perimetry

Exclusion criteria

1. Age < 18 years
2. Pregnant
3. Previous inflammatory/infectious events involving the eyes

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

ADX-2191 Three Injections

Experimental group

Treatment:

Drug: ADX-2191

Drug: ADX-2191

ADX-2191 Six Injections

Experimental group

Treatment:

Drug: ADX-2191

Drug: ADX-2191