NCT05916391RecruitingPhase 1
Gene Therapy for Diabetic Macular Edema
An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema
Source: ClinicalTrials.gov · Last updated 23 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 14 Jun 2023
- Start date
- 19 May 2023
- Primary completion date
- 1 May 2025
- Lead sponsor
- Frontera Therapeutics
- Diseases
- Diabetic eye disease
- NCT number
- NCT05916391
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 19 May 2023 to the primary completion date, 1 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Eye Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.