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Corticosteroid

EC-104 Implant for Diabetic Macular Edema (BETTIS-1 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Eclipse Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females who are at least 18 years of age at the time of informed consent
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 24
Awards & highlights

Summary

This trial will compare the safety and effectiveness of two different doses of a drug called EC-104-6M and EC-104-4M to Ozurdex in patients with diabetic retinopathy

Who is the study for?
This trial is for people with diabetic macular edema who didn't get better after anti-VEGF therapy and can handle corticosteroids without a big increase in eye pressure. It's not for those who haven't had these treatments or have other eye problems that could interfere.
What is being tested?
The study tests two doses of EC-104 against a known treatment, Ozurdex, to see which is safer and works better for diabetic retinopathy with swelling in the center of the retina. Participants are randomly assigned to one of the treatments without knowing which one they receive.
What are the potential side effects?
Possible side effects include increased eye pressure, cataract formation, and risks associated with intravitreal injections like bleeding inside the eye or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had glaucoma or high eye pressure needing treatment.
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I have had high eye pressure from steroids over 25 mm Hg.
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I have active eye disease due to diabetes with new blood vessels or bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular and Systemic Safety
Secondary study objectives
Diabetic macular edema recurrence

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: EC-104 low doseExperimental Treatment1 Intervention
Intravitreal implant of fluocinolone acetonide
Group II: EC-104 high doseExperimental Treatment1 Intervention
Intravitreal implant of fluocinolone acetonide
Group III: Dexamethasone intravitreal implantActive Control1 Intervention
Marketed product

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Who is running the clinical trial?

Eclipse Life Sciences, Inc.Lead Sponsor
~50 spots leftby Dec 2025
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