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A Study to Evaluate the Efficacy and Safety of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
Sponsor: EyeBiotech Ltd.
Summary
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (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 remigromig 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.
Official title: A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal Phase 2/3 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab (0.5mg) in Participants With Diabetic Macular Edema
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
984
Start Date
2024-08-07
Completion Date
2027-12-31
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Ranibizumab
Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
Remigromig
Remigromig is a humanized antibody formulated for intravitreal administration
Locations (183)
Scottsdale
Scottsdale, Arizona, United States
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
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Sacramento, California, United States
Santa Ana
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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
Tampa, FL
Tampa, Florida, United States
Tampa, FL
Tampa, Florida, United States
Winter Haven, FL
Winter Haven, Florida, United States
Lemont, IL
Lemont, Illinois, United States
Springfield, Illinois
Springfield, Illinois, United States
West Des Moines, IA
West Des Moines, Iowa, United States
Lenexa, Kansas
Lenexa, Kansas, United States
Wichita, Kansas
Wichita, Kansas, United States
Portland, Maine
Portland, Maine, United States
Hagerstown, MD
Hagerstown, Maryland, United States
Springfield,MA
Springfield, Massachusetts, United States
Grand Rapids, Michigan
Grand Rapids, Michigan, United States
Minneapolis, MN
Minneapolis, Minnesota, United States
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Madison, Mississippi, United States
Bloomfield, NJ
Bloomfield, New Jersey, United States
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Cherry Hill, New Jersey, United States
Liverpool, NY
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Oceanside, NY
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Rochester, NY
Rochester, New York, United States
Asheville, NC
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Cleveland, Ohio
Cleveland, Ohio, United States
Cleveland, OH
Cleveland, Ohio, United States
Youngstown, Ohio
Youngstown, Ohio, United States
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Edmond, Oklahoma, United States
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Portland, Oregon, United States
Springfield, Oregon
Springfield, Oregon, United States
Bethlehem, PA
Bethlehem, Pennsylvania, United States
Erie, PA
Erie, Pennsylvania, United States
Beaufort, SC
Beaufort, South Carolina, United States
Florence, SC
Florence, South Carolina, United States
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Germantown, Tennessee, United States
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Abilene, TX
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Bellaire, TX
Bellaire, Texas, United States
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Katy, Texas, United States
Plano, TX
Plano, Texas, United States
Round Rock, TX
Round Rock, Texas, United States
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Schertz, Texas
Schertz, Texas, United States
The Woodlands, TX
The Woodlands, Texas, United States
Willow Park, TX
Willow Park, Texas, United States
Salt Lake City, Utah
Salt Lake City, Utah, United States
Lynchburg, VA
Lynchburg, Virginia, United States
Richmond, Virginia
Richmond, Virginia, United States
Spokane, WA
Spokane, Washington, United States
Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
Santa Fe, Argentina
Rosario, Sante Fe, Argentina
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Ciudad de Cordoba, Argentina
Córdoba, Argentina
Sydney Retina Clinic
Sydney, New South Wales, Australia
Sydney, Australia
Sydney, New South Wales, Australia
Albury, Australia
Albury, Australia
Parramatta, Australia
Parramatta, Australia
Sydney, Australia
Sydney, Australia
Graz, Austria
Graz, Austria