A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME

Launched by ENNOVABIO · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ENN0403 to see how effective and safe it is for people with Diabetic Macular Edema (DME), a condition that affects the eyes and can lead to vision problems in those with diabetes. The trial will involve about 60 participants who will take ENN0403 in capsule form once a day for 12 weeks. Researchers will compare the effects of two different doses of the medication to see which one works better. Overall, the entire study will last up to 16 weeks, including time for screening and follow-up.

To be eligible for this trial, participants need to be adults aged 18 and older with either type 1 or type 2 diabetes and certain eye conditions related to DME. They should also be stable in their diabetes management and have specific levels of vision and eye measurements. Participants will be asked to follow the study guidelines closely and attend regular appointments to monitor their health and progress. This study is currently recruiting, and it's a chance to contribute to research that could improve treatments for DME.

Gender

ALL

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.