Gene Therapy(FT-003) for Wet AMD

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2028-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gene Therapy for Wet AMD

NCT05611424

Neovascular Age-related Macular Degeneration

NOT_YET_RECRUITING PHASE1

Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy

NCT05858983

Biallelic RPE65 Mutation-associated Retinal Dystrophy

RECRUITING PHASE1/PHASE2

Treatment of Age-related Macular Degeneration by Fetal Retinal Pigment Epithelial Cells Transplantation

NCT02868424

UNKNOWN EARLY_PHASE1

A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration

NCT03021785

Neovascular Age-Related Macular Degeneration

UNKNOWN PHASE1

To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)

NCT06888492

NOT_YET_RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neovascular Age-related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FT-003

Administered via intraocular injection.

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects that are willing and able to follow study procedures;
* Female or male patients 50-80 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 24-73 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

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No