A Study in Subjects With Retinitis Pigmentosa

Phase 2

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Drug: ADX-2191

• Registration Number: NCT05392179
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Study Start: 2022-07-14
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23
• Disposition First Posted: 2023-07-03
• Status Verified: 2024-04
• Disposition First Submitted: 2024-04-16
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX-2191 Three Injections	ADX-2191	-
ADX-2191 Six Injections	ADX-2191	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	16 weeks	Assessing the safety of ADX-2191 in patients with retinitis pigmentosa from AE collection

Secondary Outcome Measures

Name	Time	Method
Change in visual acuity	16 weeks	Assessing the change in visual acuity in patients with retinitis pigmentosa treated with ADX-2191 using the Early Treatment Diabetic Retinopathy (ETDRS) chart.
Change in dark-adapted retinal sensitivity	16 weeks	Assessing the change in dark-adapted retinal sensitivity in patients using dark adapted chromatic perimetry, measured in decibels
Central retinal sensitivity	16 weeks	Assessing the central retinal sensitivity in patients using microperimetry, measured in decibels
Assessment for change in central subfield foveal thickness and ellipsoid zone area/width	16 weeks	Assessing the change in central subfield foveal thickness and ellipsoid zone area/width in patients using Spectral-Domain Optical Coherence Tomography (SD-OCT) as measured in square millimeters

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States