A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
Launched by EYEBIOTECH LTD. · Apr 25, 2025
Trial Information
Current as of September 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called EYE103 for patients with Diabetic Macular Edema (DME), a condition that can cause vision loss in people with diabetes. The trial compares two different doses of EYE103 to an existing treatment called ranibizumab, which is already used to help manage this eye condition. About 960 participants will be involved, and during the first year, all patients will receive treatment every four weeks. After that, the treatment schedule may change based on individual needs.
To be eligible for this trial, participants need to be at least 18 years old and have diabetes, with a specific level of blood sugar control. They should also have experienced vision loss due to DME. Some people, such as those who are pregnant or have had recent eye surgeries, may not qualify for the study. Participants will receive careful monitoring throughout the trial, and their experiences will help researchers understand how well EYE103 works and if it is safe.
Gender
ALL
Eligibility criteria
- • 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 HbA1c of ≤12%.
- • Have a decrease in vision in the study eye determined by the investigator to be primarily the result of 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 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
About Eyebiotech Ltd.
Eyebiotech Ltd. is a pioneering biotechnology company dedicated to advancing innovative therapeutic solutions for ocular diseases and disorders. With a strong focus on research and development, Eyebiotech harnesses cutting-edge technologies and scientific expertise to create novel treatments that address unmet medical needs in ophthalmology. Committed to improving patient outcomes, the company collaborates with leading academic institutions and healthcare professionals to drive clinical trials and bring transformative therapies to market. Through its dedication to excellence and innovation, Eyebiotech aims to enhance the quality of life for individuals affected by vision-related conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fayetteville, Arkansas, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Mountain View, California, United States
Sacramento, California, United States
Hagerstown, Maryland, United States
West Columbia, South Carolina, United States
Germantown, Tennessee, United States
Abilene, Texas, United States
Bellaire, Texas, United States
Katy, Texas, United States
Round Rock, Texas, United States
The Woodlands, Texas, United States
Modesto, California, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Arecibo, Puerto Rico
Bakersfield, California, United States
Dallas, Texas, United States
Plano, Texas, United States
Santa Ana, California, United States
Deerfield Beach, Florida, United States
Redlands, California, United States
Colorado Springs, Colorado, United States
Waterford, Connecticut, United States
Fort Lauderdale, Florida, United States
Plantation, Florida, United States
Saint Petersburg, Florida, United States
Sarasota, Florida, United States
Winter Haven, Florida, United States
Lemont, Illinois, United States
West Des Moines, Iowa, United States
Springfield, Massachusetts, United States
Minneapolis, Minnesota, United States
Madison, Mississippi, United States
Bloomfield, New Jersey, United States
Liverpool, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Hickory, North Carolina, United States
Winston Salem, North Carolina, United States
Erie, Pennsylvania, United States
Beaufort, South Carolina, United States
Florence, South Carolina, United States
Ladson, South Carolina, United States
Amarillo, Texas, United States
Arlington, Texas, United States
Willow Park, Texas, United States
Lynchburg, Virginia, United States
Danbury, Connecticut, United States
Gainesville, Florida, United States
Tallahassee, Florida, United States
Cherry Hill, New Jersey, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Spokane, Washington, United States
Manchester, Connecticut, United States
Scottsdale, Arizona, United States
Wichita, Kansas, United States
Lenexa, Kansas, United States
Edina, Minnesota, United States
Wake Forest, North Carolina, United States
Santa Ana, California, United States
Durango, Colorado, United States
Waterford, Connecticut, United States
Fort Myers, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Oak Park, Illinois, United States
Springfield, Illinois, United States
Portland, Maine, United States
Towson, Maryland, United States
Grand Rapids, Michigan, United States
Winston Salem, North Carolina, United States
Springfield, Oregon, United States
Beaufort, South Carolina, United States
Ladson, South Carolina, United States
Hixson, Tennessee, United States
Johnson City, Tennessee, United States
Schertz, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Denver, Colorado, United States
Aiken, South Carolina, United States
Charleston, South Carolina, United States
Barranquilla, Colombia
Bogotá, Colombia
Cali, Colombia
Medellín, Colombia
Medellín, Colombia
Buenos Aires, Argentina
Córdoba, Argentina
Salta, Argentina
Santa Fe, Argentina
Aparecida De Goiânia, Brazil
Assis, Brazil
Belo Horizonte, Brazil
Blumenau, Brazil
Porto Alegre, Brazil
Sorocaba, Brazil
São Paulo, Brazil
Vitória, Brazil
Barranquilla, Colombia
Patients applied
Trial Officials
Charles Miller, MD PhD
Study Director
EyeBiotech Ltd.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported