EC-104 implant for treating diabetic macular edema

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 study is testing a new eye implant called EC-104 to see if it helps people with diabetic macular edema who haven't improved with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eclipse Life Sciences, Inc. (Industry-sponsored)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT06536491 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of two different doses of the EC-104 intravitreal implant compared to Ozurdex® in patients with diabetic macular edema who have not responded adequately to previous anti-VEGF therapy. Approximately 75 participants will be randomly assigned to receive either a high-dose or low-dose EC-104 implant or the standard treatment with Ozurdex®. The study aims to assess the therapeutic response and time to recurrent disease in subjects with diabetic retinopathy and center-involving diabetic macular edema. Participants will be monitored for both efficacy and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of diabetes mellitus and a history of diabetic macular edema.

Not a fit: Patients with a current or previous diagnosis of glaucoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients suffering from diabetic macular edema who have not responded well to existing therapies.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of treatments is being evaluated for the first time.

Eligibility criteria

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

Where this trial is running

Tampa, Florida

• Retina Associates of Florida, LLC — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Freddie Batalla, MBA

Conditions Diabetic Macular Edema