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Recruiting

NCT Number: NCT05874310

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

A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).

Recruiting

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Key information

Conditions

X-Linked Retinitis Pigmentosa

Age range

8 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Informed Consent Form; 4.Subjects who are confirmed with variants of RPGR ;

Exclusion criteria

1.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.

Treatment and study plan

FT-002

Genetic

Comparison of different dosages of FT-002

Primary outcomes

  1. Incidence of AEs

    Time frame: from FT-002 administration through up to 1 years

    Number and proportion of Adverse Events

Secondary outcomes

  1. Change in visual function

    Time frame: from FT-002 administration through up to 1 years

    Change in retinal function as assessed by mean retinal sensitivity within the 30-degree visual field

  2. Change in retinal structure as assessed by Optical Coherence Tomography

    Time frame: from FT-002 administration through up to 1 years

    Change in Outer Nuclear Layer Thickness from baseline as assessed by Optical Coherence Tomography

Study contacts

Contact information is provided by the study sponsor or research team.

Minghui Xue

CONTACT

[email protected]

+86-021-58206061

Xinyan Li

CONTACT

[email protected]

+86-021-58206061

Sponsors and collaborators

Lead sponsor

Frontera Therapeutics

Industry

Collaborators

  • Eye & ENT Hospital of Fudan University
  • Henan Provincial People's Hospital
  • Peking Union Medical College Hospital

Registry information

Official study title

An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraocular Administration of FT-002 in Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa.

Important dates

Study start
2023
Primary completion
2023
Study completion
2027
First posted
May 24, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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