Actively Recruiting
A Randomized, Controlled, Double-Masked Phase 2 Trial Comparing EC-104 Intravitreal Implant to Ozurdex for Diabetic Macular Edema
Led by Eclipse Life Sciences, Inc. · Updated on 2025-01-22
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two doses of the EC-104 intravitreal implant containing fluocinolone acetonide compared to the marketed dexamethasone intravitreal implant (Ozurdex4) in people with diabetic retinopathy and center-involving diabetic macular edema. This study focuses on participants who had a less than optimal response to prior anti-VEGF therapy and were previously treated with corticosteroids without a significant increase in eye pressure. It is a Phase 2, randomized, double-masked, multicenter trial designed to compare these treatments.
CONDITIONS
Brief Title
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older
- Willing and able to provide signed informed consent and comply with study visits and examinations
- Diagnosis of Type 1 or Type 2 diabetes mellitus with diabetic macular edema
- Current hemoglobin A1c value of 10.0 or less under medical care for diabetes management
- Study eye with visual acuity between 20/40 and 20/400 (Early Treatment Diabetic Retinopathy Study BCVA score 6 to 70 letters)
You will not qualify if you...
- Previous or current diagnosis of glaucoma or ocular hypertension requiring medical or surgical treatment
- History of steroid-induced intraocular pressure elevation above 25 mm Hg
- Presence of active proliferative diabetic retinopathy such as new blood vessel growth on the optic disc, elsewhere in the eye, iris, or angle, or vitreous hemorrhage associated with active neovascularization
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.
1 visit (in-person)
Duration - Through Week 24
Participants receive an intravitreal implant injection of either EC-104 high dose, EC-104 low dose, or dexamethasone intravitreal implant to treat diabetic macular edema.
Regular visits to monitor ocular and systemic safety and treatment response
Trial Site Locations
Total: 1 location
1
Retina Associates of Florida, LLC
Tampa, Florida, United States, 33609
Actively Recruiting
Research Team
F
Freddie Batalla, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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