Actively Recruiting
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)
Led by EnnovaBio · Updated on 2025-02-21
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two doses of ENN0403 capsules in adults with diabetic macular edema (DME), a condition causing vision loss due to swelling in the retina. This Phase 2, multicenter, randomized, parallel study will include about 60 participants to understand how well the drug works and how safe it is for people with DME. Participants will be randomly assigned to receive either a low dose or a high dose of ENN0403, taken orally once a day for 12 weeks. The study includes up to 2 weeks of screening to determine eligibility, followed by 12 weeks of treatment, and then a 2-week follow-up period, making the total study duration up to 16 weeks. During the study, researchers will measure changes in the thickness of the central retina (CRT) and visual acuity at various points, including weeks 4, 8, and 12. They will also monitor for any eye-related or other side effects. Participants will undergo regular assessments and tests to track these outcomes, ensuring close observation throughout the treatment and follow-up phases.
CONDITIONS
Brief Title
A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Understand and agree to follow the study procedures and medication schedule
- Diagnosed with type 1 or type 2 diabetes mellitus with HbA1c ≤ 10.0% and stable blood sugar control for at least 1 month before screening
- Vision decrease mainly caused by diabetic macular edema in the study eye
- Best Corrected Visual Acuity (BCVA) between 24 and 73 letters (Snellen 20/320 to 20/40) at screening and baseline
- Central Retinal Thickness (CRT) of at least 300 µm measured by Optical Coherence Tomography (OCT) at screening
You will not qualify if you...
- Eye disease or history other than diabetic macular edema causing irreversible vision loss in the study eye
- Previous glaucoma filtration surgery in the study eye or planned surgery during the study
- Previous vitreoretinal surgery in the study eye
- Use of intraocular hormone drugs within 6 months or periocular/systemic hormone drugs within 3 months before baseline
- Intraocular injection of VEGF within 3 months before baseline in any eye
- History of idiopathic or autoimmune uveitis in any eye
- Uncontrolled glaucoma (IOP ≥ 25 mmHg despite treatment) in any eye
- Allergy to the investigational drug or any ingredients used in treatment
- Use of other investigational drugs or devices within 3 months or 5 half-lives prior to baseline
- Any other factors deemed inappropriate for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants take ENN0403 capsules orally once a day for 12 weeks to treat diabetic macular edema.
Visits at weeks 4, 8, and 12 for assessments
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300384
Actively Recruiting
Research Team
L
Lei Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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