NCT05611424

Gene Therapy for Wet AMD

Not yet recruiting Phase 1 Last updated 26 April 2023

What this trial tests

Phase 1 trial testing FT-003 in Neovascular Age-related Macular Degeneration in 18 participants. Not yet recruiting.

Timeline

1 May 2023

Primary endpoint
30 November 2024

30 December 2027

Quick facts

Lead sponsor	Frontera Therapeutics
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 May 2023
Primary completion	30 November 2024
Estimated completion	30 December 2027

Drugs / interventions tested

• FT-003

Conditions studied

• Neovascular Age-related Macular Degeneration — all drugs for Neovascular Age-related Macular Degeneration →

Sponsor

Frontera Therapeutics

Who can join

45 and older, any sex, with Neovascular Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antioxidants and Mechanistic Insights for Managing Dry Age-Related Macular Degeneration.
   Basyal D, Lee S, Kim HJ. · · 2024 · cited 15× · PMID 38790673 · DOI 10.3390/antiox13050568
2. Advances in ophthalmic therapeutic delivery: A comprehensive overview of present and future directions.
   Torkashvand A, Izadian A, Hajrasouliha A. · · 2024 · cited 12× · PMID 38986847 · DOI 10.1016/j.survophthal.2024.07.002
3. Gene therapy for age-related macular degeneration: a promising frontier in vision preservation.
   Hushmandi K, Lam HY, Wong WM, Tan W, et al · · 2025 · cited 8× · PMID 40394614 · DOI 10.1186/s12964-025-02246-4
4. Toward lentiviral vectors for antiangiogenic ocular gene therapy.
   Askou AL, Jakobsen TS, Corydon TJ. · · 2023 · cited 5× · PMID 37663649 · DOI 10.1016/j.omtm.2023.08.007
5. Advances in Precision Therapeutics and Gene Therapy Applications for Retinal Diseases: Impact and Future Directions.
   AlEissa MM, Alhawsawi AA, Alonazi R, Magharbil E, et al · · 2025 · cited 2× · PMID 40725503 · DOI 10.3390/genes16070847
6. Genetic engineering and the eye.
   Murphy R, Martin KR. · · 2025 · cited 2× · PMID 39516652 · DOI 10.1038/s41433-024-03441-2
7. Nanomaterial-Based Anti-Angiogenic Gene Therapy for Retinal Neovascular Diseases: Mechanistic Insights and Preclinical Advances.
   Zeng L, Wei Y, Qiu Y, Bi R, et al · · 2025 · cited 1× · PMID 40989889 · DOI 10.2147/ijn.s521960
8. Adeno-Associated Virus Vectors in Retinal Gene Therapy: Challenges, Innovations, and Future Directions.
   Huang J, Li J, Xu X, Li K. · · 2025 · cited 1× · PMID 40723812 · DOI 10.3390/biom15070940