EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema

NCT06536491 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EC104-CS-201
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Ocular and Systemic Safety

  Incidence of Adverse events

  Through Week 24

Secondary Outcomes (1)

• Diabetic macular edema recurrence

  Through Week 24

Study Arms (3)

EC-104 high dose

EXPERIMENTAL

Intravitreal implant of fluocinolone acetonide

Drug: EC-104 high dose

EC-104 low dose

EXPERIMENTAL

Intravitreal implant of fluocinolone acetonide

Drug: EC-104 low dose

Dexamethasone intravitreal implant

ACTIVE COMPARATOR

Marketed product

Drug: Dexamethasone intravitreal implant

Interventions

EC-104 high dose DRUG

Intravitreal injection

EC-104 high dose

EC-104 low dose DRUG

Intravitreal injection

EC-104 low dose

Dexamethasone intravitreal implant DRUG

Marketed product intravitreal injection

Dexamethasone intravitreal implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females who are at least 18 years of age at the time of informed consent
• 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
• Diagnosis of diabetes mellitus (Type 1 or Type 2), with history of diabetic macular edema (DME) \< = years duration prior to Screening Visit 1
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eclipse Life Sciences, Inc.: lead

Study Sites (1)

Retina Associates of Florida, LLC

Tampa, Florida, 33609, United States

RECRUITING

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Freddie Batalla, MBA

CONTACT

919-443-5542; BETTIS-1@eclipselifesciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Evaluators of efficacy study assessments will be masked. The injecting physician and the injection technician or clinical assistant preparing the IP for administration will be unmasked to the identity of the specific investigational product (IP)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Computer generated equal randomization

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)