EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema (BETTIS-1)

A Randomized, Controlled, Subject- and Evaluator-Masked, Phase 2 Clinical Trial Comparing EC-104 Intravitreal Implant to Ozurdex® for the Treatment of Diabetic Macular Edema (BETTIS-1)

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: EC-104 high dose; Drug: EC-104 low dose; Drug: Dexamethasone intravitreal implant

Detailed Description

Approximately 75 subjects who meet entry criteria will be randomized 1:1:1 to EC-104-6M high-dose (FA 0.14 mg) implant or EC-104-4M low-dose (FA 0.092 mg) implant or Ozurdex® (dexamethasone IVT implant 0.7 mg), with the goal of achieving approximately 20 subjects per group with a positive therapeutic response in their study eyes, who are evaluable in the primary endpoint analysis to assess efficacy. Subjects with a positive therapeutic response at Week 4 will be included in the primary and secondary endpoint analyses to assess efficacy for "Time to recurrent disease." Subjects who do not achieve a positive therapeutic response will be classified as suboptimal responders. While suboptimal responders will not be included in the primary and the secondary endpoint analyses to assess efficacy for "Time to recurrent disease," they will remain in the study and will be followed prospectively, with inclusion in the remaining endpoints to assess efficacy and all safety endpoint analyses

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Freddie Batalla, MBA; Phone Number: 919-443-5542; Email: BETTIS-1@eclipselifesciences.com

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33609
      • Recruiting
      • Retina Associates of Florida, LLC
      • Contact: Cindy Lopez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or females who are at least 18 years of age at the time of informed consent
2. Willing and able to provide signed informed consent (participant or legally authorized representative) prior to any study-related procedures and to comply with all study visits and cooperate with all examinations
3. Diagnosis of diabetes mellitus (Type 1 or Type 2), with history of diabetic macular edema (DME) < = years duration prior to Screening Visit 1

4. Currently monitored hemoglobin A1c values ≤ 10.0 while under the care of a qualified medical provider for diabetes mellitus management, unless provider allows value variance

   Inclusion criteria for the study eye (all of the below criteria must be met in the same eye):

5. Early Treatment Diabetic Retinopathy Study BCVA score ≤ 70 letters (Snellen equivalent 20/40 or worse) and ≥ 20 letters (Snellen equivalent 20/400) in at least 1 eye

Exclusion Criteria:

1. 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
2. History of steroid-induced IOP elevation > 25 mm Hg
3. Presence of active proliferative diabetic retinopathy, defined as active neovascularization of disc (NVD), neovascularization elsewhere (NVE), neovascularization of iris (NVI), neovascularization of angle (NVA), or vitreous hemorrhage in the setting of active NVD or NVE

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EC-104 high dose; Intravitreal implant of fluocinolone acetonide	Drug: EC-104 high dose; Intravitreal injection
Experimental: EC-104 low dose; Intravitreal implant of fluocinolone acetonide	Drug: EC-104 low dose; Intravitreal injection
Active Comparator: Dexamethasone intravitreal implant; Marketed product	Drug: Dexamethasone intravitreal implant; Marketed product intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular and Systemic Safety	Incidence of Adverse events	Through Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetic macular edema recurrence	Time (days) to recurrence	Through Week 24

Collaborators and Investigators

• Sponsor: Eclipse Life Sciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Edema; Macular Edema; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: EC104-CS-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No