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Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa

A Phase I/II Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of FT-002 Subretinal Injection in Subjects With RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa.

NCT06492850•Frontera Therapeutics

View on ClinicalTrials.gov

Summary

The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).

Eligibility

Age

8 - 45 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form;
•Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;
•Clinically diagnosed XLRP, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.;

Exclusion Criteria

•Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 1, 2024

Primary Completion Date

August 1, 2025

Completion Date

February 1, 2026

Last Updated

July 9, 2024

Enrollment

ESTIMATED participants

Conditions

X-Linked Retinitis Pigmentosa (XLRP)

Interventions

FT-002

GENETIC

Contacts

Xinyan Li

CONTACT

+86-021-58206061 xinyan.li@fronteratherapeutics.com

Minghui Xue

CONTACT

+86-021-58206061 minghui.xue@fronteratherapeutics.com

A Phase 2 Open-label Study to Evaluate the Safety of Laruparetigene Zovaparvovec Administered Bilaterally in Male Participants With X-Linked Retinitis Pigmentosa

NCT07174726

X-Linked Retinitis Pigmentosa (XLRP)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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