Actively Recruiting
Randomized Study Comparing EC-104 Intravitreal Implant Doses and Dexamethasone Implant for Diabetic Macular Edema Phase 2, Double-Masked Controlled Trial by Eclipse Life Sciences
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
Researchers are evaluating the safety and effectiveness of different intravitreal implants for treating diabetic macular edema (DME) in adults who have had a poor response to anti-VEGF therapy and prior corticosteroid treatment without significant eye pressure increases. This Phase 2, randomized, masked, multicenter study compares two doses of EC-104 fluocinolone acetonide (high-dose 0.14 mg and low-dose 0.092 mg) implants with the marketed dexamethasone intravitreal implant, Ozurdex4 (0.7 mg). The goal is to find treatments that help manage DME in patients with diabetic retinopathy who have center-involving DME and suboptimal prior treatment response. About 75 participants will be randomly assigned in equal groups to receive either the EC-104 high-dose implant, the EC-104 low-dose implant, or the Ozurdex implant. After treatment, participants showing a positive response at Week 4 will be included in primary and secondary analyses evaluating the time until disease recurrence. Those who do not respond positively will still remain in the study and be followed for other efficacy and safety outcomes. Treatments are delivered as intravitreal injections directly into the eye. Participants will undergo assessments including vision tests using the Early Treatment Diabetic Retinopathy Study (ETDRS) scoring, safety monitoring of eye pressure, and other ocular and systemic evaluations through Week 24. The study aims to monitor both ocular and overall safety during this period. The entire participant involvement includes follow-up visits and examinations to track treatment effects, disease progression, and any side effects over the study duration.
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
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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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