drugset / Trial / NCT06536491
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
RandomizedParallel-groupDouble-blindTreatment
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 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).
Timeline
- Start
- 2024-08-19
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 0.7 mg | Intravitreal |
| Subject | fluocinolone acetonide | Small molecule | 0.092 mg | Intravitreal |
| Subject | fluocinolone acetonide | Small molecule | 0.14 mg | Intravitreal |