A Study in Subjects With Retinitis Pigmentosa

NCT ID: NCT05392179

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2023-06-23

Brief Summary

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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

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Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADX-2191 Three Injections

Group Type EXPERIMENTAL

ADX-2191

Intervention Type DRUG

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

ADX-2191 Six Injections

Group Type EXPERIMENTAL

ADX-2191

Intervention Type DRUG

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

Interventions

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ADX-2191

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

Intervention Type DRUG

ADX-2191

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke Eye Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ADX-2191-RP-001

Identifier Type: -

Identifier Source: org_study_id

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