Actively Recruiting
A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
Led by EnnovaBio · Updated on 2025-02-21
60
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 the study process and agree to follow all procedures and medication rules
- Diagnosed with type 1 or type 2 diabetes with HbA1c 6.0% and stable blood sugar control for at least 1 month before screening
- Vision loss mainly caused by diabetic macular edema in the study eye
- Best corrected visual acuity (BCVA) letter score between 24 and 73 at screening and baseline
- Optical Coherence Tomography (OCT) showing central retinal thickness (CRT) at fovea of at least 300 bcm at screening
You will not qualify if you...
- Any eye disease or history other than diabetic macular edema causing irreversible vision loss in the study eye
- Previous glaucoma filtration surgery or planned glaucoma surgery in the study eye
- Previous vitreoretinal surgery in the study eye
- Intraocular hormone treatments within 6 months or periocular/systemic hormone treatments within 3 months before baseline
- Any intraocular injection of VEGF within 3 months before baseline
- History of idiopathic or autoimmune uveitis in any eye
- Uncontrolled glaucoma in any eye (intraocular pressure 625 mmHg after treatment)
- Allergy to the study drug or its ingredients
- Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline
- Other conditions deemed inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300384
Actively Recruiting
Research Team
L
Lei Huang
CONTACT
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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