Actively Recruiting

Phase 1
Phase 2
Age: 8Years - 45Years
MALE
NCT06492850

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

Led by Frontera Therapeutics · Updated on 2024-07-09

32

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 45Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male subjects willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign informed consent
  • Age 18 to 45 years old at time of consent for Phase I dose escalation stage
  • Age 8 to 45 years old at time of consent for Phase II dose expansion stage
  • Clinically diagnosed with X-linked retinitis pigmentosa (XLRP) with symptoms such as night blindness, visual field loss, or vision loss
Not Eligible

You will not qualify if you...

  • Presence of other retinal degenerative diseases caused by known inherited retinal disease gene variants
  • Prior receipt of any gene therapy product

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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Research Team

X

Xinyan Li

CONTACT

M

Minghui Xue

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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