A Study in Subjects With Retinitis Pigmentosa

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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX-2191

Drug

Monthly intravitreal injections of ADX-2191 (400 µg in 0.05 mL) for a total of three injections. Evaluation through week 16.

Primary outcomes

Number of Subjects With Serious Adverse Events

Time frame: The safety assessment period was 16 weeks.

The proportion of subjects that experience at least one serious adverse event

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-label, Phase II Study of ADX-2191 in Subjects With Retinitis Pigmentosa

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: May 26, 2022
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed