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

NCT04850118 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-04-07

No results posted yet for this 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

  • X-Linked Retinitis Pigmentosa

Interventions

BIOLOGICAL

rAAV2tYF-GRK1-hRPGRco

Adeno-associated virus vector expressing a human RPGR gene

DRUG

Control

Untreated Control Group 3

Sponsors & Collaborators

  • Beacon Therapeutics

    lead INDUSTRY

Principal Investigators

  • Carrie Reichley · Beacon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2026-06-30
Completion
2031-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04850118 on ClinicalTrials.gov