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ACTIVE NOT RECRUITING

NCT06957080

PHASE2/PHASE3

A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Sponsor: EyeBiotech Ltd.

View on ClinicalTrials.gov

Summary

EYE-RES-103 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

1054

Start Date

2025-04-16

Completion Date

2028-03-30

Last Updated

2026-01-06

Healthy Volunteers

Conditions

Diabetic Macular Edema (DME)

Interventions

DRUG

EYE103

EYE103 is a humanized antibody formulated for intravitreal administration

DRUG

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

Salt Lake City, UT

Salt Lake City, Utah, United States

West Jordan, Utah

West Jordan, Utah, United States

Lynchburg, VA

Lynchburg, Virginia, United States

Richmond, VA

Richmond, Virginia, United States

Bellevue, Washington

Bellevue, Washington, United States

Burlington, Washington

Burlington, Washington, United States

Spokane, WA

Spokane, Washington, United States

Buenos Aires, Argentina

Cordoba, Argentina

Córdoba, Argentina

Cordoba, Argentina

Córdoba, Argentina

Salta, Argentina

Santa Fe, Argentina

Aparecida De Goiania, Brazil

Aparecida de Goiânia, Brazil

Aparecida de Goiania, Brazil

Aparecida de Goiânia, Brazil

Assis, Brazil

Belo Horizonte, Brazil

Blumenau, Brazil

Porto Alegre, Brazil

Sao Paulo, Brazil

São Paulo, Brazil

Sao Paulo, Brazil

São Paulo, Brazil

Sorocaba, Brazil

Vitoria, Brazil

Vitória, Brazil

Barranquilla, Colombia

Bogata, Colombia

Bogotá, Colombia

Cali, Colombia

Medelin, Colombia

Medellín, Colombia

Medellin, Colombia

Medellín, Colombia

Nagoya City, Japan

Nagoya, Aichi-ken, Japan

Hirosaki, Japan

Hirosaki, Aomori, Japan

Sakura, Japan

Sakura, Chiba, Japan

Yoshida-gun, Japan

Yoshida-gun, Fukui, Japan

Fukuoka-shi, Japan

Fukuoka, Fukuoka, Japan

Kurume City, Japan

Kurume, Fukuoka, Japan

Fukuoka-shi, Japan

Fukuoka, Higashi-ku Fukuoka, Japan

Asahikawa, Japan

Asahikawa, Hokkaido, Japan

Amagasaki, Japan

Amagasaki, Hyōgo, Japan

Mito, Japan

Mito, Ibaraki, Japan

Kita-gun, Japan

Kita-gun, Kagawa-ken, Japan

Kagoshima City, Japan

Kagoshima, Kagoshima-ken, Japan

Tokorozawa-shi, Japan

Tokorozawa-shi, Saitama, Japan

Shimotsuke-shi, Japan

Shimotsuke-shi, Tochigi, Japan

Hachioji, Japan

Hachiōji, Tokyo, Japan

Meguro-ku, Japan

Meguro-ku, Tokyo, Japan

Taito-ku, Japan

Taito-ku, Tokyo, Japan

Ube-shi, Japan

Ube-shi, Yamaguchi, Japan

Fukushima, Japan

Miyazaki, Japan

Osaka, Japan

Tokushima, Japan

Tokyo, Japan

Yamagata, Japan

Arecibo, PR

Arecibo, Puerto Rico

San Juan, Puerto Rico