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A Study in Subjects With Retinitis Pigmentosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05392179
Recruitment Status : Completed
First Posted : May 26, 2022
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Drug: ADX-2191 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase II Study of ADX-2191 in Subjects With Retinitis Pigmentosa
Actual Study Start Date : July 14, 2022
Actual Primary Completion Date : June 23, 2023
Actual Study Completion Date : June 23, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ADX-2191 Three Injections Drug: ADX-2191
Monthly intravitreal injections of ADX-2191 (400 µg in 0.05 mL) for a total of three injections. Evaluation through week 16.
Experimental: ADX-2191 Six Injections 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: 16 weeks ]
    Assessing the safety of ADX-2191 in patients with retinitis pigmentosa from AE collection


Secondary Outcome Measures :
  1. Change in visual acuity [ Time Frame: 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.

  2. Central retinal sensitivity [ Time Frame: 16 weeks ]
    Assessing the central retinal sensitivity in patients using microperimetry, measured in decibels

  3. Change in dark-adapted retinal sensitivity [ Time Frame: 16 weeks ]
    Assessing the change in dark-adapted retinal sensitivity in patients using dark adapted chromatic perimetry, measured in decibels

  4. Assessment for change in central subfield foveal thickness and ellipsoid zone area/width [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05392179


Locations
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United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.
More Information
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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05392179    
Other Study ID Numbers: ADX-2191-RP-001
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aldeyra Therapeutics, Inc.:
ADX-2191
Methotrexate
Retinitis Pigmentosa
Rhodopsin Mutation P23H
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn