Gene Therapy for Wet AMD

NCT ID: NCT05611424

Last Updated: 2023-04-26

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-12-30

Brief Summary

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FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Neovascular Age-related Macular Degeneration
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FT003 Dose 1

Low dose of FT-003

Group Type EXPERIMENTAL

FT-003

Intervention Type GENETIC

Administered via intraocular injection.

FT003 Dose 2

Mid dose of FT-003

Group Type EXPERIMENTAL

FT-003

Intervention Type GENETIC

Administered via intraocular injection.

FT003 Dose 3

High dose of FT-003

Group Type EXPERIMENTAL

FT-003

Intervention Type GENETIC

Administered via intraocular injection.

Interventions

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FT-003

Administered via intraocular injection.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Subjects that are willing and able to follow study procedures;
* Female or male patients ≥45 years old at the time of signing the ICF;
* Clinically diagnosed with nAMD;
* Presence of active CNV
* The best corrected visual acuity (BCVA) of the studied eye is ≤ 53 letters;

Exclusion Criteria

• Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Tianjin Medical University Eye Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

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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Peirong Lu, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochou University

Xiaorong Li, Professor

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Eye Hospital

Hanyi Min

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Guangming Wan

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Central Contacts

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Xinyan Li

Role: CONTACT

+86-021-58206061

Minghui Xue

Role: CONTACT

+86-021-58206061

Other Identifiers

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FT003WA-1

Identifier Type: -

Identifier Source: org_study_id

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