Status:
RECRUITING
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
Lead Sponsor:
Eclipse Life Sciences, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 an...
Detailed Description
Approximately 75 subjects who meet entry criteria will be randomized 1:1:1 to EC-104-6M high-dose (FA 0.14 mg) implant or EC-104-4M low-dose (FA 0.092 mg) implant or Ozurdex® (dexamethasone IVT implan...
Eligibility Criteria
Inclusion
- 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 (participant or legally authorized representative) prior to any study-related procedures and to comply with all study visits and cooperate with all examinations
- Diagnosis of diabetes mellitus (Type 1 or Type 2), with history of diabetic macular edema (DME) \< = years duration prior to Screening Visit 1
- Currently monitored hemoglobin A1c values ≤ 10.0 while under the care of a qualified medical provider for diabetes mellitus management, unless provider allows value variance
- Inclusion criteria for the study eye (all of the below criteria must be met in the same eye):
- Early Treatment Diabetic Retinopathy Study BCVA score ≤ 70 letters (Snellen equivalent 20/40 or worse) and ≥ 20 letters (Snellen equivalent 20/400) in at least 1 eye
Exclusion
- Previous or current diagnosis of any form of glaucoma (defined as cup-to-disc ratio \> 0.7) or ocular hypertension (documented intraocular pressure (IOP) \> 21 mm Hg without glaucomatous disc damage) requiring medical or surgical intervention
- History of steroid-induced IOP elevation \> 25 mm Hg
- Presence of active proliferative diabetic retinopathy, defined as active neovascularization of disc (NVD), neovascularization elsewhere (NVE), neovascularization of iris (NVI), neovascularization of angle (NVA), or vitreous hemorrhage in the setting of active NVD or NVE
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06536491
Start Date
August 19 2024
End Date
December 31 2025
Last Update
January 22 2025
Active Locations (1)
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1
Retina Associates of Florida, LLC
Tampa, Florida, United States, 33609