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A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
Sponsor: EyeBiotech Ltd.
Summary
EYE-RES-103 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
1054
Start Date
2025-04-16
Completion Date
2028-01-11
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Remigromig
Remigromig is a humanized antibody formulated for intravitreal administration
Ranibizumab
Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
Locations (164)
Gilbert, Arizona
Gilbert, Arizona, United States
Phoenix, Arizona
Phoenix, Arizona, United States
Scottsdale, AZ
Scottsdale, Arizona, United States
Fayetteville, AR
Fayetteville, Arkansas, United States
Bakersfield, CA
Bakersfield, California, United States
Encino, California
Encino, 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, CA
Santa Ana, California, United States
Santa Ana
Santa Ana, California, United States
Colorado Springs, CO
Colorado Springs, Colorado, United States
Denver, CO
Denver, Colorado, United States
Durango, CO
Durango, Colorado, United States
Danbury, CT
Danbury, Connecticut, United States
Manchester, CT
Manchester, Connecticut, United States
Waterford, CT
Waterford, 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, FL
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
Joliet, Illinois
Joliet, Illinois, United States
Lemont, IL
Lemont, Illinois, United States
Oak Park, IL
Oak Park, Illinois, United States
Springfield, IL
Springfield, Illinois, United States
West Des Moines, IA
West Des Moines, Iowa, United States
Lenexa, KS
Lenexa, Kansas, United States
Wichita, Kansas
Wichita, Kansas, United States
Portland, ME
Portland, Maine, United States
Baltimore, Maryland
Baltimore, Maryland, United States
Hagerstown, MD
Hagerstown, Maryland, United States
Towson, MD
Towson, Maryland, United States
Springfield,MA
Springfield, Massachusetts, United States
Grand Rapids, MI
Grand Rapids, Michigan, United States
Edina, MN
Edina, Minnesota, United States
Minneapolis, MN
Minneapolis, Minnesota, United States
Madison, MS
Madison, Mississippi, United States
Henderson, Nevada
Henderson, Nevada, United States
Bloomfield, NJ
Bloomfield, New Jersey, United States
Cherry Hill, NJ
Cherry Hill, New Jersey, United States
Albuquerque, New Mexico
Albuquerque, New Mexico, United States
Great Neck, New York
Great Neck, New York, United States
Hauppauge, New York
Hauppauge, New York, United States
Liverpool, NY
Liverpool, New York, United States
New York, NY
New York, New York, United States
Rochester, NY
Rochester, New York, United States
Asheville, NC
Asheville, North Carolina, United States
Cary, North Carolina
Cary, North Carolina, United States
Hickory, NC
Hickory, North Carolina, United States
Wake Forest, NC
Wake Forest, North Carolina, United States
Winston Salem, NC
Winston-Salem, North Carolina, United States
Winston-Salem, NC
Winston-Salem, North Carolina, United States
Tulsa, Oklahoma
Tulsa, Oklahoma, United States
Portland, OR
Portland, Oregon, United States
Portland, Oregon
Portland, Oregon, United States
Salem, Oregon
Salem, Oregon, United States
Springfield, OR
Springfield, Oregon, United States
Bethlehem, PA
Bethlehem, Pennsylvania, United States
Erie, PA
Erie, Pennsylvania, United States
Aiken, SC
Aiken, South Carolina, United States
Beaufort, NC
Beaufort, South Carolina, United States
Beaufort, SC
Beaufort, South Carolina, United States
Bluffton, NC
Bluffton, South Carolina, United States
Charleston, SC
Charleston, South Carolina, United States
Florence, SC
Florence, South Carolina, United States
Ladson, NC
Ladson, South Carolina, United States
Ladson, SC
Ladson, South Carolina, United States
West Columbia, SC
West Columbia, South Carolina, United States
Germantown, TN
Germantown, Tennessee, United States
Hixson, TN
Hixson, Tennessee, United States
Johnson City, TN
Johnson City, Tennessee, United States
Knoxville, TN
Knoxville, Tennessee, United States
Nashville, TN
Nashville, Tennessee, United States
Abilene, TX
Abilene, Texas, United States
Amarillo, TX
Amarillo, Texas, United States
Arlington, TX
Arlington, Texas, United States
Austin, TX
Austin, Texas, United States
Bellaire, TX
Bellaire, Texas, United States
Burleson, Texas
Burleson, Texas, United States
Dallas, TX
Dallas, Texas, United States
Fort Worth, TX
Fort Worth, Texas, United States
Katy, TX
Katy, Texas, United States
Plano, TX
Plano, Texas, United States
Round Rock, TX
Round Rock, Texas, United States
San Antonio, TX
San Antonio, Texas, United States
San Marcos, Texas
San Marcos, Texas, United States
Schertz, TX
Schertz, Texas, United States
The Woodlands, TX
The Woodlands, Texas, United States
Willow Park, TX
Willow Park, Texas, United States