NCT05392179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 23, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

March 28, 2022

Results QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Retinitis Pigmentosa

Keywords

ADX-2191MethotrexateRetinitis PigmentosaRhodopsin Mutation P23H

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Serious Adverse Events

    The proportion of subjects that experience at least one serious adverse event

    The safety assessment period was 16 weeks.

Study Arms (2)

ADX-2191 Three Injections

EXPERIMENTAL
Drug: ADX-2191

ADX-2191 Six Injections

EXPERIMENTAL
Drug: ADX-2191

Interventions

ADX-2191DRUG

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

ADX-2191 Three Injections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • Pregnant
  • Previous inflammatory/infectious events involving the eyes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Director of Clinical Trials
Organization
Aldeyra Therapeutics, Inc.
bcavanagh@aldeyra.com
781-257-3063

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 26, 2022

Study Start

July 14, 2022

Primary Completion

June 23, 2023

Study Completion

June 23, 2023

Last Updated

April 23, 2026

Results First Posted

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)