Diabetic Macular Edema (DME)Phase 2NCT06708260
A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects With DME
A Phase 2 study testing ENN0403, low dose and ENN0403, high dose in people with Diabetic Macular Edema (DME), run by EnnovaBio at 9 sites in China.
Trial summary
This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- ENN0403, low dose and ENN0403, high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesChina
- Study dates
- 12 Dec 2024to 20 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent;
- Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study;
- Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);
- The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;
- BCVA letter score of ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit and at baseline. If both eyes meet the inclusion criteria, the study eye will be determined by the investigator from a medical perspective. ( If both eyes meet the inclusion criteria，the eye with poor baseline vision will be selected as the study eye; If the BCVA number is the same, choose the eye with the thicker CRT as the study eye) ；
- Optical Coherence Tomography (OCT) foveal CRT at screening measuring ≥300 μm.
Who cannot join
- Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;
- Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;
- Study eye had previously undergone vitreoretinal surgery;
- Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;
- Any eye received intraocular injection of VEGF within 3 months prior to baseline;
- History of idiopathic or autoimmune uveitis in any eye;
Show all 10Show fewer
- Uncontrolled glaucoma in any eye (defined as IOP ≥25 mmHg after treatment with anti-glaucoma drugs)
- History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment;
- Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer);
- Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610075
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200040
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, 050027
Shanxi Eye Hospital
Taiyuan, Shanxi, 030002
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, 261041
Xian No.1 Hospital
Xi’an, Shanxi, 710002
Hebei Eye Hospital
Xingtai, Hebei, 054001
Zhengzhou Second Hospital
Zhengzhou, Henan, 450015
About this study
Official title: A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects With Diabetic Macular Edema (DME)
This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- ENN0403, low dose, ENN0403, high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENN0403, low doseDrug
ENN0403 capsules will be orally administered once a day for 12 weeks.
ENN0403, high doseDrug
ENN0403 capsules will be orally administered once a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ENN0403 low dose treatment arm | Experimental | Not described Receives: Drug: ENN0403, low dose |
| ENN0403 high dose treatment arm | Experimental | Not described Receives: Drug: ENN0403, high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Central Retinal Thickness (CRT) at week 12
Measured: week 12
Secondary outcomes (3)
Change from baseline in Best Corrected Visual Acuity (BCVA) at week 4, 8, and 12
Measured: week 4, 8, 12
Change from baseline in CRT at week 4 and 8
Measured: week 4, 8
Incidence of ocular and non-ocular TEAE and SAE
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start12 Dec 2024
- Primary completion12 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnnovaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708260
- Sponsor's protocol ID
- ENN0403-P2-CN-03
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT06708260
- Acronym / sponsor ID
- ENN0403-P2-CN-03
- Conditions
- Diabetic Macular Edema (DME)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EnnovaBioIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 27 Nov 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.
This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENN0403 low dose treatment arm | Experimental | Drug: ENN0403, low dose |
| ENN0403 high dose treatment arm | Experimental | Drug: ENN0403, high dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent;
- Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study;
- Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);
- The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;
- BCVA letter score of ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit and at baseline. If both eyes meet the inclusion criteria, the study eye will be determined by the investigator from a medical perspective. ( If both eyes meet the inclusion criteria，the eye with poor baseline vision will be selected as the study eye; If the BCVA number is the same, choose the eye with the thicker CRT as the study eye) ；
Key exclusion criteria (10 listed)
- Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;
- Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;
- Study eye had previously undergone vitreoretinal surgery;
- Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;
- Any eye received intraocular injection of VEGF within 3 months prior to baseline;
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 |
|---|---|---|
| ENN0403, low doseENN0403 capsules will be orally administered once a day for 12 weeks. | Drug | ENN0403 low dose treatment arm |
| ENN0403, high doseENN0403 capsules will be orally administered once a day for 12 weeks. | Drug | ENN0403 high dose treatment arm |
Primary outcome
Change from baseline in Central Retinal Thickness (CRT) at week 12
Time frame: week 12
3 secondary outcomes
Change from baseline in Best Corrected Visual Acuity (BCVA) at week 4, 8, and 12
Time frame: week 4, 8, 12
Change from baseline in CRT at week 4 and 8
Time frame: week 4, 8
Incidence of ocular and non-ocular TEAE and SAE
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENN0403, low dose and ENN0403, high dose in people with Diabetic Macular Edema (DME), run by EnnovaBio at 9 sites 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Central Retinal Thickness (CRT) at week 12 (time frame: 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 5 Oct 2026.