Gene Therapy for Diabetic Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FT-003.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Genetic FT-003
Administration via intraocular injection
Primary outcome measures
- Safety and tolerability after FT-003 injection [Time frame: Whthin 52 weeks after administration]
Secondary outcome measures (1)
- Preliminary effectiveness after FT-003 injection [Time frame: Whthin 52 weeks after administration]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Eye Hospital — Tianjin
Identifiers
NCT: NCT05916391 · FT003DM-1