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Clinical Trials in Australia / NCT06571045
Active, not recruiting Phase 2/3

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 Australia tracker
Sponsor
EyeBiotech Ltd
Phase
Phase 2/3
Started
2024-08-07
Last updated
2026-09-30

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
No
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)

FacilityCityRegionStatus
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 Australia

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

Other trials for the same condition

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema 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 Australia