NCT05916391

Gene Therapy for Diabetic Macular Edema

Recruiting now Phase 1 Last updated 23 June 2023

What this trial tests

Phase 1 trial testing FT-003 in Diabetic Macular Edema in 18 participants. Currently enrolling.

Timeline

19 May 2023

Primary endpoint
1 May 2025

1 May 2028

Quick facts

Lead sponsor	Frontera Therapeutics
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	19 May 2023
Primary completion	1 May 2025
Estimated completion	1 May 2028
Sites	1 location across China

Drugs / interventions tested

• FT-003

Conditions studied

• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

Frontera Therapeutics

Who can join

18 and older, any sex, with Diabetic Macular Edema. 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 central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.

Publications & conference data

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

1. 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
2. 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
3. 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
4. Genetic engineering and the eye.
   Murphy R, Martin KR. · · 2025 · cited 2× · PMID 39516652 · DOI 10.1038/s41433-024-03441-2
5. 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
6. 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
7. The Central Role of Oxidative Stress in Diabetic Retinopathy: Advances in Pathogenesis, Diagnosis, and Therapy.
   Tuli N, Moroz H, Jaffer A, Kulbay M, et al · · 2026 · PMID 41681711 · DOI 10.3390/diagnostics16030392
8. The economic impact of retinal diseases for which gene therapy is emerging: a systematic literature review.
   Willmington C, Kirby A, Murphy A. · · 2025 · PMID 41353311 · DOI 10.1186/s13561-025-00707-7