A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

NCT06571045 · tracked via the Priya Life Science Germany tracker

Sponsor

EyeBiotech Ltd

Phase

Phase 2/3

Started

2024-08-07

Last updated

2026-08-20

Condition(s) studied

Diabetic Macular Edema (DME)

Investigational drug(s) / intervention(s)

Ranibizumab →EYE103 →

Ranibizumab: Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema

EYE103: EYE103 is a humanized antibody formulated for intravitreal administration

Study summary

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)

In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.

Approximately 960 participants will be entered in the study.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity * Be male or female ≥18 years of age. * Have type 1 or type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%. * Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (DME). Exclusion Criteria: * Be pregnant or breastfeeding * History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening * Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening * Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone) * If treatment-experienced for DME have a history of any of the following treatments within the noted time windows: * Have had prior treatment in the study eye with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye * Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept \[2 mg\], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit

Primary outcome measure(s)

Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart — Baseline and Week 52
The change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.

Trial sites (183)

Facility	City	Region
Scottsdale	Scottsdale	Arizona
Fayetteville, Arkansas	Fayetteville	Arkansas
Springdale, Arkansas	Springdale	Arkansas
Bakersfield, CA	Bakersfield	California
Glendale, CA	Glendale	California
Modesto, CA	Modesto	California
Mountain View, CA	Mountain View	California
Redlands, CA	Redlands	California
Sacramento, CA	Sacramento	California
Sacramento, CA	Sacramento	California
Santa Ana	Santa Ana	California
Colorado Springs, CO	Colorado Springs	Colorado
Denver, Colorado	Denver	Colorado
Danbury, CT	Danbury	Connecticut
Manchester, CT	Manchester	Connecticut
Waterford,CT	Waterford	Connecticut
Deerfield Beach, FL	Deerfield Beach	Florida
Fort Lauderdale, FL	Fort Lauderdale	Florida
Fort Myers,FL	Fort Myers	Florida
Gainesville, FL	Gainesville	Florida
Orlando, Florida	Orlando	Florida
Plantation, FL	Plantation	Florida
Sarasota, FL	Sarasota	Florida
Saint Petersburg, FL	St. Petersburg	Florida
Tallahassee, FL	Tallahassee	Florida
Tampa, FL	Tampa	Florida
Tampa, FL	Tampa	Florida
Winter Haven, FL	Winter Haven	Florida
Lemont, IL	Lemont	Illinois
Springfield, Illinois	Springfield	Illinois
West Des Moines, IA	West Des Moines	Iowa
Lenexa, Kansas	Lenexa	Kansas
Wichita, Kansas	Wichita	Kansas
Portland, Maine	Portland	Maine
Hagerstown, MD	Hagerstown	Maryland
Springfield,MA	Springfield	Massachusetts
Grand Rapids, Michigan	Grand Rapids	Michigan
Minneapolis, MN	Minneapolis	Minnesota
Madison, MS	Madison	Mississippi
Bloomfield, NJ	Bloomfield	New Jersey

+ 143 more sites — see the full list on the official registry below.

More EyeBiotech Ltd. trials in Germany

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) Recruiting

Other trials for the same condition

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME Active, not recruiting

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06571045 on ClinicalTrials.gov ↗ ← All trials in Germany