Diabetic Macular EdemaPhase 1NCT05916391
Gene Therapy for Diabetic Macular Edema
A Phase 1 study testing FT-003 in people with Diabetic Macular Edema, run by Frontera Therapeutics at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 18 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2023to 1 May 2028
- Phase
- Phase 1
- 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 years and older
- 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 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
Who cannot join
- 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
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: 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
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- FT-003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT-003Genetic
Administration 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: Whthin 52 weeks after administration
Secondary outcomes (1)
Preliminary effectiveness after FT-003 injection
Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline
Measured: Whthin 52 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start19 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Central Involvement Diabetic Macular Edema
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Eye Hospital, Peking Union Medical College Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- Xiaorong Li, Professor, Principal investigator, Tianjin Medical University Eye HospitalHanyi Min, Professor, Principal investigator, Peking Union Medical College HospitalGuangming Wan, Professor, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916391
- Sponsor's protocol ID
- FT003DM-1
- Status last verified
- Apr 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- 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 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05916391
- Acronym / sponsor ID
- FT003DM-1
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Frontera TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Eye Hospital, Peking Union Medical College Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 19 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Jun 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Central Involvement Diabetic Macular Edema
| 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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-003Administration via intraocular injection | Genetic | FT003 Dose 1, FT003 Dose 2, FT003 Dose 3 |
Primary outcome
Safety and tolerability after FT-003 injection
Time frame: Whthin 52 weeks after administration
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
1 secondary outcome
Preliminary effectiveness after FT-003 injection
Time frame: Whthin 52 weeks after administration
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 23 Jun 2023.
- 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
Hanyi Min, Professor principal investigator
Peking Union Medical College Hospital
Guangming Wan, Professor principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 5 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 23 Jun 2023. 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 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.
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 (+862158206061, 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: Whthin 52 weeks after administration). 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 23 Jun 2023.