Gene Therapy for Wet AMD

NCT05611424 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: FT003WA-1
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability after FT-003 injection

  Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

  At Week 52

Secondary Outcomes (1)

• Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline

  At Week 52

Study Arms (3)

FT003 Dose 1

EXPERIMENTAL

Low dose of FT-003

Genetic: FT-003

FT003 Dose 2

EXPERIMENTAL

Mid dose of FT-003

Genetic: FT-003

FT003 Dose 3

EXPERIMENTAL

High dose of FT-003

Genetic: FT-003

Interventions

FT-003 GENETIC

Administered via intraocular injection.

FT003 Dose 1; FT003 Dose 2; FT003 Dose 3

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frontera Therapeutics: lead
• The First Affiliated Hospital of Soochow University: collaborator
• Tianjin Medical University Eye Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyan Li

CONTACT

+86-021-58206061; Xinyan.li@fronteratherapeutics.com

Minghui Xue

CONTACT

+86-021-58206061; minghui.xue@fronteratherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Neovascular Age-related Macular Degeneration

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 10, 2022
• Study Start: May 1, 2023
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share