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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 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.

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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.

Conditions Studied

X-Linked Retinitis Pigmentosa

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

FieldValue
Enrollment Target 85 participants
Start Date 2024-03-14
Est. Completion 2029-10
Phase Phase 2

Sponsor

Beacon Therapeutics

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04850118

The ClinicalTrials.gov registry entry for NCT04850118 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 48-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (77% higher). The listed sponsor is Beacon Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.