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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06492876
- Acronym / sponsor ID
- FT003-CD101
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, FT-003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Frontera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FT003 Dose 1 | Experimental | Genetic: FT-003Low dose of FT-003 |
| FT003 Dose 2 | Experimental | Genetic: FT-003Mid dose of FT-003 |
| FT003 Dose 3 | Experimental | Genetic: FT-003High dose of FT-003 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT-003Administered via intraocular injection. | Genetic | FT003 Dose 1, FT003 Dose 2, FT003 Dose 3 |
Primary outcome
Safety and tolerability after FT-003 injection
Time frame: At Week 12
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
1 secondary outcome
To evaluate the efficacy after FT-003 injection
Time frame: At Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaorong Li, Professor principal investigator
Tianjin Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FT-003 in people with Diabetic Macular Edema, run by Frontera Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyan Li (+86-021-58206061, Xinyan.li@fronteratherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability after FT-003 injection (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.