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A Study to Evaluate the Efficacy and Safety of 2 Doses of 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 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.
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
2025-08-12
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
EYE103
EYE103 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
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
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
Madison, MS
Madison, Mississippi, United States
Bloomfield, NJ
Bloomfield, New Jersey, United States
Cherry Hill, NJ
Cherry Hill, New Jersey, United States
Liverpool, NY
Liverpool, New York, United States
Oceanside, NY
Oceanside, New York, United States
Rochester, NY
Rochester, New York, United States
Asheville, NC
Asheville, North Carolina, United States
Hickory, NC
Hickory, North Carolina, United States
Wake Forest, MC
Wake Forest, North Carolina, United States
Winston Salem, NC
Winston-Salem, North Carolina, United States
Cleveland, Ohio
Cleveland, Ohio, United States
Cleveland, OH
Cleveland, Ohio, United States
Youngstown, Ohio
Youngstown, Ohio, United States
Edmond, OK
Edmond, Oklahoma, United States
Portland, OR
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
Ladson, SC
Ladson, South Carolina, United States
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West Columbia, South Carolina, United States
Germantown, TN
Germantown, Tennessee, United States
Hixson, Tennessee
Hixson, Tennessee, United States
Johnson City, Tennessee
Johnson City, Tennessee, United States
Knoxville, TN
Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
Abilene, TX
Abilene, Texas, United States
Amarillo, TX
Amarillo, Texas, United States
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Arlington, TX
Arlington, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
Bellaire, TX
Bellaire, Texas, United States
Dallas, TX
Dallas, Texas, United States
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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
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
Ciudad de Cordoba, Argentina
Córdoba, Argentina, Argentina
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
Caba, Buenos Aires, Argentina
Cordoba, Argentina
Córdoba, Córdoba Province, Argentina
Santa Fe, Argentina
Rosario, Santa Fe Province, Argentina
Santa Fe, Argentina
Rosario, Sante Fe, Argentina
Buenos Aires, Argentina
CABA, Argentina
Albury, Australia
Albury, Australia, Australia
Parramatta, Australia
Parramatta, Australia, Australia
Sydney, Australia
Sydney, Australia, Australia
Sydney Retina Clinic
Sydney, New South Wales, Australia
Sydney, Australia
Sydney, New South Wales, Australia
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Innsbruck, Austria, Austria
Vienna, Austria
Vienna, Vienna, Austria
Graz, Austria
Graz, Austria
Vienna, Austria
Vienna, Austria
Medellin, Colombia
Medellín, Antioquia, Colombia
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Medellin, Colombia
Medellín, Colombia, Colombia
Bogota, Columbia
Bogotá, Columbia, Colombia
Cali, Colombia
Cali, Valle del Cauca Department, Colombia
Osijek, Croatia
Osijek, Croatia
Prague, Czechia
Prague, Prague, Czechia
Mlada Boleslav, Czechia
Mladá Boleslav, Czechia
Nachod, Czechia
Náchod, Czechia
Prague, Czechia
Prague, Czechia
Cedex, France
Dijon, Cedex, France
Lyon, France
Lyon, France, France
Paris, France
Paris, Paris, France
Creteil, France
Créteil, France
Marseille, France
Marseille, France
Paris, France
Paris, France
Paris, France
Paris, France
Saint Cyr sur Loire, France
Saint-Cyr-sur-Loire, France
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Frankfurt, Germany, Germany
Hanover, Germany
Hanover, Germany, Germany
Munchen, Germany
München, Germany, Germany
Munster, Germany
Münster, Germany, Germany
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Budapest, Budapest, Hungary
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Budapest, Hungary, Hungary
Budapest, Hungary
Budapest, Hungary, Hungary
Debrecen, Hungary
Debrecen, Hungary, Hungary
Zalaegerszeg, Hungary
Zalaegerszeg, Hungary, Hungary
Budapest, Hungry
Budapest, Hungary
Pecs, Hungary
Pécs, Hungary
Szeged, Hungary
Szeged, Hungary
Rehovot, Israel
Rehovot, Israel, Israel
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Be’er Ya‘aqov, Israel
Haifa, Israel
Haifa, Israel
Jerusalem, Israel
Jerusalem, Israel
Petah Tikva, Israel
Petah Tikva, Israel
Tel Aviv, Israel
Tel Aviv, Israel
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Bologna, Italy, Italy
Milano, Italy
Milan, Italy, Italy
Roma, Italy
Roma, Italy, Italy
Udine, Italy
Udine, Italy, Italy
Milano, Italy
Milan, Milano, Italy
Rome, Italy
Rome, Rome, Italy
Firenze, Italy
Florence, Italy
Milano, Italy
Milan, Italy
Riga, Latvia
Riga, Rīga, Latvia
Riga, Latvia
Riga, Rīga, Latvia
Gdansk, Poland
Gdansk, Gdansk, Poland
Bialystok, Poland
Bialystok, Poland, Poland
Bydgoszcz, Poland
Bydgoszcz, Poland, Poland
Katowice, Poland
Katowice, Poland, Poland
Krakow, Poland
Krakow, Poland, Poland
Tarnowskie Gory, Poland
Tarnowskie Góry, Poland, Poland
Bydgoszcz, Poland
Bydgoszcz, Poland
Gdansk, Poland
Gdansk, Poland
Olsztyn, Poland
Olsztyn, Poland
Porto, Portugal
Porto, Porto District, Portugal
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Coimbra, Portugal
Coimbra, Portugal
Coimbra, Portugal
Arecibo, PR
Arecibo, PR, Puerto Rico
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Trebišov, Slovakia, Slovakia
Trencin, Slovakia
Trenčín, Slovakia, Slovakia
Zilina, Slovakia
Žilina, Slovakia, Slovakia
Barcelona, Spain
Barcelona, Barcelona, Spain
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Seville, Sevilla, Spain
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Barcelona, Spain, Spain
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Barcelona, Spain, Spain
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Santiago de Compostela, Spain, Spain
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Zaragoza, Spain, Spain
Valencia, Spain
Burjassot, Valencia, Spain
Barcelona, Spain
Barcelona, Spain
Ankara, Turkey
Ankara, Turkey, Turkey (Türkiye)
Ankara, Turkey
Ankara, Turkey, Turkey (Türkiye)
Balcova, Turkey
Balçova, Turkey, Turkey (Türkiye)
London, UK
London, Middlesex, United Kingdom
Bradford, United Kingdom
Bradford, United Kingdom, United Kingdom
Liverpool, United Kingdom
Liverpool, United Kingdom, United Kingdom
Sunderland, United Kingdom
Sunderland, United Kingdom, United Kingdom
Wolverhamptom, United Kingdom
Wolverhampton, United Kingdom, United Kingdom
York, United Kingdom
York, UnitedKingdom, United Kingdom
Bristol, UK
Bristol, United Kingdom