A Study in Subjects With Retinitis Pigmentosa

Aldeyra Therapeutics, Inc.8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinitis Pigmentosa

Interventions

ADX-2191DRUG

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

ADX-2191DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke Eye Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.