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ACTIVE NOT RECRUITING Phase 2

A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP

NCT04850118 · View on ClinicalTrials.gov ↗

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.

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

9 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beacon Therapeutics, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04850118 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, Pennsylvania, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04850118?

The interventions under investigation include: rAAV2tYF-GRK1-hRPGRco (BIOLOGICAL), Control (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04850118?

This trial is sponsored by Beacon Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial