Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06536491
The ClinicalTrials.gov registry entry for NCT06536491 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,793-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (98% lower). The listed sponsor is Eclipse Life Sciences, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)
RECRUITING · Phase 1
-
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
RECRUITING · Phase 1
-
Kamuvudine-9 (K9) in Diabetic Macular Edema
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
RECRUITING · Phase 1
-
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
ACTIVE NOT RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.