Diabetic Macular EdemaPhase 1/2NCT06492876
Gene Therapy for DME
A Phase 1/2 study testing FT-003 in people with Diabetic Macular Edema, run by Frontera Therapeutics at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- FT-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 15 Nov 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin,China, 300392
Xiaorong Li, Professor
About this study
Official title: A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- FT-003
- Keywords
- Diabetic Macular Edema, FT-003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT-003Genetic
Administered via intraocular injection.
| Study group | Role | What they receive |
|---|---|---|
| FT003 Dose 1 | Experimental | Low dose of FT-003 Receives: Genetic: FT-003 |
| FT003 Dose 2 | Experimental | Mid dose of FT-003 Receives: Genetic: FT-003 |
| FT003 Dose 3 | Experimental | High dose of FT-003 Receives: Genetic: FT-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after FT-003 injection
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
Measured: At Week 12
Secondary outcomes (1)
To evaluate the efficacy after FT-003 injection
the BCVA /CST change from baseline
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Nov 2023
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaorong Li, Professor, Principal investigator, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492876
- Sponsor's protocol ID
- FT003-CD101
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No