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

NCT ID: NCT05874310

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2027-11-01

Brief Summary

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

Detailed Description

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Conditions

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X-Linked Retinitis Pigmentosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

X-linked retinitis pigmentosa patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose FT-002

Intraocular injection of a single low dose of FT-002

Group Type EXPERIMENTAL

FT-002

Intervention Type GENETIC

Comparison of different dosages of FT-002

Intermediate dose FT-002

Intraocular injection of a single Intermediate dose of FT-002

Group Type EXPERIMENTAL

FT-002

Intervention Type GENETIC

Comparison of different dosages of FT-002

High dose FT-002

Intraocular injection of a single High dose of FT-002

Group Type EXPERIMENTAL

FT-002

Intervention Type GENETIC

Comparison of different dosages of FT-002

Interventions

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FT-002

Comparison of different dosages of FT-002

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Frontera Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gezhi Xu

Role: PRINCIPAL_INVESTIGATOR

Eye & ENT Hospital of Fudan University

Ruifang Sui

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Eye & ENT hospital of Fudan university

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinyan Li

Role: CONTACT

+86-021-58206061

Minghui Xue

Role: CONTACT

+86-021-58206061

Facility Contacts

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Ruifang Sui, Professor

Role: primary

Gezhi Xu, Professor

Role: primary

Jihong Wu, Professor

Role: backup

Other Identifiers

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FT002RP-1

Identifier Type: -

Identifier Source: org_study_id

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