Back to resultsA Study in Subjects With Retinitis Pigmentosa
Primary Purpose
Retinitis Pigmentosa
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADX-2191
ADX-2191
Sponsored by
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring ADX-2191, Methotrexate, Retinitis Pigmentosa, Rhodopsin Mutation P23H
Eligibility Criteria
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
Sites / Locations
- Duke Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ADX-2191 Three Injections
ADX-2191 Six Injections
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with adverse events (AEs)
Assessing the safety of ADX-2191 in patients with retinitis pigmentosa from AE collection
Secondary Outcome Measures
Change in visual acuity
Assessing the change in visual acuity in patients with retinitis pigmentosa treated with ADX-2191 using the Early Treatment Diabetic Retinopathy (ETDRS) chart.
Central retinal sensitivity
Assessing the central retinal sensitivity in patients using microperimetry, measured in decibels
Change in dark-adapted retinal sensitivity
Assessing the change in dark-adapted retinal sensitivity in patients using dark adapted chromatic perimetry, measured in decibels
Assessment for change in central subfield foveal thickness and ellipsoid zone area/width
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
Full Information
NCT ID
NCT05392179
First Posted
March 28, 2022
Last Updated
June 29, 2023
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05392179
Brief Title
A Study in Subjects With Retinitis Pigmentosa
Official Title
An Open-label, Phase II Study of ADX-2191 in Subjects With Retinitis Pigmentosa
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
June 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
ADX-2191, Methotrexate, Retinitis Pigmentosa, Rhodopsin Mutation P23H
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADX-2191 Three Injections
Arm Type
Experimental
Arm Title
ADX-2191 Six Injections
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ADX-2191
Intervention Description
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
Intervention Name(s)
ADX-2191
Intervention Description
Monthly intravitreal injections of ADX-2191 (400 µg in 0.05 mL) for a total of six injections. Evaluation through week 16.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Assessing the safety of ADX-2191 in patients with retinitis pigmentosa from AE collection
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in visual acuity
Description
Assessing the change in visual acuity in patients with retinitis pigmentosa treated with ADX-2191 using the Early Treatment Diabetic Retinopathy (ETDRS) chart.
Time Frame
16 weeks
Title
Central retinal sensitivity
Description
Assessing the central retinal sensitivity in patients using microperimetry, measured in decibels
Time Frame
16 weeks
Title
Change in dark-adapted retinal sensitivity
Description
Assessing the change in dark-adapted retinal sensitivity in patients using dark adapted chromatic perimetry, measured in decibels
Time Frame
16 weeks
Title
Assessment for change in central subfield foveal thickness and ellipsoid zone area/width
Description
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
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study in Subjects With Retinitis Pigmentosa
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