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

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Diabetic Macular Edema (DME)

In brief

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.

Key facts

Study ID

NCT06571045

Run by

EyeBiotech Ltd.

People needed

984

Starts

2024-08-07

Expected to finish

2027-12-31

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Fayetteville, Arkansas — Fayetteville, Arkansas, United States
• Springdale, Arkansas — Springdale, Arkansas, United States
• Bakersfield, CA — Bakersfield, California, United States
• Glendale, CA — Glendale, California, United States
• Modesto, CA — Modesto, California, United States
• Mountain View, CA — Mountain View, California, United States
• Redlands, CA — Redlands, California, United States
• Sacramento, CA — Sacramento, California, United States
• Sacramento, CA — Sacramento, California, United States
• Santa Ana — Santa Ana, California, United States
• Colorado Springs, CO — Colorado Springs, Colorado, United States
• Denver, Colorado — Denver, Colorado, United States
• Danbury, CT — Danbury, Connecticut, United States
• Manchester, CT — Manchester, Connecticut, United States
• Waterford,CT — Waterford, Connecticut, United States
• Deerfield Beach, FL — Deerfield Beach, Florida, United States
• Fort Lauderdale, FL — Fort Lauderdale, Florida, United States
• Fort Myers,FL — Fort Myers, Florida, United States
• Gainesville, FL — Gainesville, Florida, United States
• Orlando, Florida — Orlando, Florida, United States
• Plantation, FL — Plantation, Florida, United States
• Sarasota, FL — Sarasota, Florida, United States
• Saint Petersburg, FL — St. Petersburg, Florida, United States
• Tallahassee, FL — Tallahassee, Florida, United States
• Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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