EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema

Part of paid clinical trials in Tampa, Florida.

Sponsor
Eclipse Life Sciences, Inc.
Study ID
NCT06536491
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EC-104 high dose — DRUG
    Intravitreal injection
  • EC-104 low dose — DRUG
    Intravitreal injection
  • Dexamethasone intravitreal implant — DRUG
    Marketed product intravitreal injection

Study Details

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).

Key Dates

Start date
Aug 19, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EC-104 high dose
    Intravitreal implant of fluocinolone acetonide
  • Experimental: EC-104 low dose
    Intravitreal implant of fluocinolone acetonide
  • Active Comparator: Dexamethasone intravitreal implant
    Marketed product

Primary Outcome Measure

Ocular and Systemic Safety [ Time Frame: Through Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Associates of Florida, LLCTampaFlorida33609
Cindy Lopez

Find similar trials in Tampa, FL

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Associates of Florida, LLC· Tampa, FL

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