Gene Therapy for Wet AMD

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05611424
• Other study ID #: FT003WA-1
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2023
• Source: Frontera Therapeutics
• Contact: Xinyan Li
• Phone: +86-021-58206061
• Email: Xinyan.li[@]fronteratherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 30, 2027
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Genetic:
• FT-003
Administered via intraocular injection.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Frontera Therapeutics	Peking Union Medical College Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University Eye Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability after FT-003 injection	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)	At Week 52
Secondary	Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline		At Week 52