Gene Therapy for Wet AMD

April 24, 2023 updated by: Frontera Therapeutics

An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Neovascular Age-related Macular Degeneration

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FT003 Dose 1
Low dose of FT-003
Genetic: FT-003
Administered via intraocular injection.
Experimental: FT003 Dose 2
Mid dose of FT-003
Genetic: FT-003
Administered via intraocular injection.
Experimental: FT003 Dose 3
High dose of FT-003
Genetic: FT-003
Administered via intraocular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability after FT-003 injection
Time Frame: At Week 52
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
At Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline
Time Frame: At Week 52
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frontera Therapeutics

Collaborators

Peking Union Medical College Hospital
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital of Zhengzhou University
Tianjin Medical University Eye Hospital

Investigators

  • Principal Investigator: Peirong Lu, Professor, The First Affiliated Hospital of Soochou University
  • Principal Investigator: Xiaorong Li, Professor, Tianjin Medical University Eye Hospital
  • Principal Investigator: Hanyi Min, Peking Union Medical College Hospital
  • Principal Investigator: Guangming Wan, The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

November 30, 2024

Study Completion (Anticipated)

December 30, 2027

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT003WA-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neovascular Age-related Macular Degeneration

Clinical Trials on FT-003

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe