MedTrace Logo

A Study Comparing Two Doses of AGTC-501 in Male Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (DAWN)

NCT06275620 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-30

No results posted yet for this study

Summary

This Phase 2 study is a non-randomized, open-label, study of the safety of AGTC-501 in participants with XLRP who have previously been treated with a full-length AAV vector-based gene therapy targeting RPGR protein.

Conditions

  • X-Linked Retinitis Pigmentosa

Interventions

BIOLOGICAL

AGTC-501 (high dose and standard corticosteroid regimen)

Adeno-associated virus vector expressing a human RPGR gene

BIOLOGICAL

AGTC-501 (low dose and standard corticosteroid regimen)

Adeno-associated virus vector expressing a human RPGR gene

BIOLOGICAL

AGTC-501 (high dose and modified corticosteroid regimen)

Adeno-associated virus vector expressing a human RPGR gene

Sponsors & Collaborators

  • Beacon Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2025-11-30
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06275620 on ClinicalTrials.gov