Actively Recruiting
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
Led by Eclipse Life Sciences, Inc. · Updated on 2025-01-22
75
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide \[FA\] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).
CONDITIONS
Official 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 who are at least 18 years of age at the time of informed consent
- Willing and able to provide signed informed consent and comply with all study visits and examinations
- Diagnosis of diabetes mellitus (Type 1 or Type 2) with history of diabetic macular edema (DME) of any duration
- Currently have hemoglobin A1c values 4.0 or less under diabetes care, unless the provider allows a variance
- Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA score of 70 letters or less (20/40 or worse) and at least 20 letters (20/400) in at least one eye
You will not qualify if you...
- Previous or current diagnosis of any form of glaucoma or ocular hypertension requiring medical or surgical intervention
- History of steroid-induced intraocular pressure (IOP) elevation greater than 25 mm Hg
- Presence of active proliferative diabetic retinopathy, including active neovascularization of the disc, elsewhere, iris, angle, or vitreous hemorrhage associated with neovascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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