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NCT04850118 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP
A Phase 2 study of X-Linked Retinitis Pigmentosa, sponsored by Beacon Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT04850118: Active Phase 2 study of X-Linked Retinitis Pigmentosa, sponsored by Beacon Therapeutics.
NCT04850118 is a Phase 2 study of X-Linked Retinitis Pigmentosa that is active but no longer recruiting, run by Beacon Therapeutics. The registered enrollment target is 85 participants, above the 48-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (77% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04850118, a Phase 2 study of X-Linked Retinitis Pigmentosa, is active but no longer recruiting, sponsored by Beacon Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate and compare the safety, efficacy, and tolerability of 2 doses of a recombinant adeno-associated virus vector (AGTC-501/laruparetigene zovaparvovec )) to an untreated control group in male participants with X-linked retinitis pigmentosa caused by RPGR mutations.
Primary Outcome
LLVA(Low Luminance Visual Acuity) will be determined by adding a neutral density filter to the refraction using standard ETDRS (Early Treatment of Diabetic Retinopathy) visual acuity or tumbling "E" chart
Conditions Studied
Interventions
- BIOLOGICAL rAAV2tYF-GRK1-hRPGRco
- DRUG Control
Study Locations (20)
Texas
- Retina Consultants of Texas - Bellaire
- Retina Foundation of the Southwest - Dallas
- Baylor Eye Institute - Houston
- Retina Consultants of San Antonio Texas - San Antonio
Pennsylvania
- The Center for Advanced Retinal & Ocular Therapeutics University of Pennsylvania Perelman School of Medicine - Philadelphia
- Mid Atlantic Retina - Philadelphia
- University of Pittsburgh - Pittsburgh
Florida
- University of Florida Health Jacksonville, Department of Ophthalmology - Jacksonville
- Bascom Palmer Eye Institute- University of Miami - Miami
Ohio
- Cincinnati Eye Institute - Cincinnati
- Cole Eye Institute - Cleveland Clinic - Cleveland
Arizona
- Retina Macula Institute of Arizona - Scottsdale
California
- Children's Hospital Los Angeles - Los Angeles
Indiana
- Midwest Eye Institute (Retina Partners Midwest) - Carmel
Maryland
- Wilmer Eye Institute at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2024-03-14 |
| Est. Completion | 2029-10 |
| Phase | Phase 2 |
What the registry record for NCT04850118 still lists
NCT04850118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 48-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (77% higher).
The record links to 1 condition, with X-Linked Retinitis Pigmentosa appearing as the primary indexed condition, and to 2 interventions - of which rAAV2tYF-GRK1-hRPGRco is the first listed.
NCT04850118 names 20 study sites across 13 states, led by Texas, Pennsylvania, Florida.
Frequently Asked Questions
What is clinical trial NCT04850118 about?
NCT04850118 is a clinical study titled "A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP". This study will evaluate and compare the safety, efficacy, and tolerability of 2 doses of a recombinant adeno-associated virus vector (AGTC-501/laruparetigene zovaparvovec )) to an untreated control group in male participants with X-linked retinitis pigmentosa caused by RPGR mutations.
What is the current status of trial NCT04850118?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2024-03-14. Estimated completion is 2029-10.
What conditions does trial NCT04850118 study?
This clinical trial studies the following conditions: X-Linked Retinitis Pigmentosa.
What interventions are being tested in trial NCT04850118?
The interventions under investigation include: rAAV2tYF-GRK1-hRPGRco (BIOLOGICAL), Control (DRUG).
Who is sponsoring clinical trial NCT04850118?
This trial is sponsored by Beacon Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04850118 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for X-Linked Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04850118's enrollment target sits among peer trials
85 3rd of 8 higher than 6 of 8 other X-Linked Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other X-Linked Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE)
ACTIVE NOT RECRUITING · Phase 2
-
A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)
ACTIVE NOT RECRUITING · Phase 2
-
4D-125 in Patients With X-Linked Retinitis Pigmentosa (XLRP)
ACTIVE NOT RECRUITING · Phase 1
-
Safety and Efficacy of rAAV2tYF-GRK1-RPGR in Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations
ACTIVE NOT RECRUITING · Phase 1
-
Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
ACTIVE NOT RECRUITING · Phase 3
-
Long-term Follow-up Gene Therapy Study for RPGR- XLRP
COMPLETED
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