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NCT06536491 · ClinicalTrials.gov registry record · Phase 1
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
A Phase 1 study of Diabetic Macular Edema, sponsored by Eclipse Life Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06536491: Recruiting Phase 1 study of Diabetic Macular Edema, sponsored by Eclipse Life Sciences.
NCT06536491 is a Phase 1 study of Diabetic Macular Edema that is actively recruiting participants, run by Eclipse Life Sciences. The registered enrollment target is 75 participants, below the 3,793-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06536491, a Phase 1 study of Diabetic Macular Edema, is actively recruiting participants, sponsored by Eclipse Life Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Incidence of Adverse events
Conditions Studied
Interventions
- DRUG EC-104 high dose
- DRUG EC-104 low dose
- DRUG Dexamethasone intravitreal implant
Study Locations (1)
Florida
- Retina Associates of Florida, LLC - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What NCT06536491 shows while recruiting
NCT06536491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 3,793-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 3 interventions - of which EC-104 high dose is the first listed.
NCT06536491 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06536491 about?
NCT06536491 is a clinical study titled "EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema". 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....
What is the current status of trial NCT06536491?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2024-08-19. Estimated completion is 2025-12-31.
What conditions does trial NCT06536491 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT06536491?
The interventions under investigation include: EC-104 high dose (DRUG), EC-104 low dose (DRUG), Dexamethasone intravitreal implant (DRUG).
Who is sponsoring clinical trial NCT06536491?
This trial is sponsored by Eclipse Life Sciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06536491 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06536491's enrollment target sits among peer trials
75 34th of 63 higher than 30 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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