A Study in Subjects With Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

Official title:

An Open-label, Phase II Study of ADX-2191 in Subjects With Retinitis Pigmentosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392179
• Other study ID #: ADX-2191-RP-001
• Status: Completed
• Phase: Phase 2
• Start date: July 14, 2022
• Est. completion date: June 23, 2023

Study information

• Verified date: April 2024
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

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

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Assessing the safety of ADX-2191 in patients with retinitis pigmentosa from AE collection	16 weeks
Secondary	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.	16 weeks
Secondary	Central retinal sensitivity	Assessing the central retinal sensitivity in patients using microperimetry, measured in decibels	16 weeks
Secondary	Change in dark-adapted retinal sensitivity	Assessing the change in dark-adapted retinal sensitivity in patients using dark adapted chromatic perimetry, measured in decibels	16 weeks
Secondary	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	16 weeks