Gene Therapy for DME
A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME
1 other identifier
interventional
78
1 country
1
Brief Summary
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2023
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2023
CompletedFirst Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2028
ExpectedJuly 9, 2024
July 1, 2024
1 year
July 1, 2024
July 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability after FT-003 injection
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
At Week 12
Secondary Outcomes (1)
To evaluate the efficacy after FT-003 injection
At Week 24
Study Arms (3)
FT003 Dose 1
EXPERIMENTALLow dose of FT-003
FT003 Dose 2
EXPERIMENTALMid dose of FT-003
FT003 Dose 3
EXPERIMENTALHigh dose of FT-003
Interventions
Eligibility Criteria
You may qualify if:
- Subjects that are willing and able to follow study procedures;
- Female or male patients 18-74 years old at the time of signing the ICF;
- Clinically diagnosed with CI-DME;
- The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;
You may not qualify if:
- Presence of any other intraocular diseases other than 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Eye Hospital
Tianjin, Tianjin,China, 300392, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaorong Li, Professor
Tianjin Medical University Eye Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 9, 2024
Study Start
November 15, 2023
Primary Completion
November 15, 2024
Study Completion (Estimated)
November 15, 2028
Last Updated
July 9, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share