NCT05611424Not yet recruitingPhase 1
Gene Therapy for Wet AMD
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
Source: ClinicalTrials.gov · Last updated 26 Apr 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 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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 2 Nov 2022
- Start date
- 1 May 2023
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Frontera Therapeutics
- Diseases
- Macular degeneration
- NCT number
- NCT05611424
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 1 May 2023 to the primary completion date, 30 Nov 2024
- No sites listed in no 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 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.
Who the study is looking for
- 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;
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.