Evaluating ENN0403 for Diabetic Macular Edema

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 study is testing whether two different doses of a new oral medication called ENN0403 can help improve vision in people with diabetic macular edema.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: EnnovaBio (industry)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06708260 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, parallel study aims to assess the efficacy and safety of two different doses of ENN0403 administered orally to patients with diabetic macular edema (DME). Approximately 60 participants will be randomly assigned to receive either a low or high dose of ENN0403 once daily. The study will include a screening period of up to 2 weeks, followed by 12 weeks of treatment and a 2-week follow-up, totaling 16 weeks. The primary focus is to determine how well ENN0403 improves vision in patients affected by DME.

Who should consider this trial

Good fit: Ideal candidates include individuals with type 1 or type 2 diabetes and diabetic macular edema who have stable glycemic control.

Not a fit: Patients with uncontrolled diabetes or those whose vision loss is not primarily due to diabetic macular edema may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients suffering from diabetic macular edema.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating diabetic macular edema with novel therapies.

Eligibility criteria

Inclusion Criteria:

1. Provide written informed consent;
2. 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;
3. 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);
4. The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;
5. 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) ；
6. Optical Coherence Tomography (OCT) foveal CRT at screening measuring ≥300 μm.

Exclusion Criteria:

1. Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;
2. Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;
3. Study eye had previously undergone vitreoretinal surgery;
4. Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;
5. Any eye received intraocular injection of VEGF within 3 months prior to baseline;
6. History of idiopathic or autoimmune uveitis in any eye;
7. Uncontrolled glaucoma in any eye (defined as IOP ≥25 mmHg after treatment with anti-glaucoma drugs)
8. History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment;
9. Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer);
10. Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lei Huang

Conditions: Diabetic Macular Edema