NCT05916391 Gene Therapy for Diabetic Macular Edema
| NCT ID | NCT05916391 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Frontera Therapeutics |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2023-05-19 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subjects that are willing and able to follow study procedures; * Female or male patients ≥18 years old at the time of signing the ICF; * Clinically diagnosed with CI-DME * HbA1c≤10% * The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters Exclusion Criteria: * Presence of any other intraocular diseases other than CI-DME 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
Contact & Investigator
Xiaorong Li, Professor
PRINCIPAL INVESTIGATOR
Tianjin Medical University Eye Hospital
Frequently Asked Questions
Who can join the NCT05916391 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05916391 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05916391 currently recruiting?
Yes, NCT05916391 is actively recruiting participants. Contact the research team at Xinyan.li@fronteratherapeutics.com for enrollment information.
Where is the NCT05916391 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05916391 clinical trial?
NCT05916391 is sponsored by Frontera Therapeutics. The principal investigator is Xiaorong Li, Professor at Tianjin Medical University Eye Hospital. The trial plans to enroll 18 participants.