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RECRUITING
NCT07734844
PHASE3

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO

Sponsor: Kodiak Sciences Inc

View on ClinicalTrials.gov

Summary

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO

Official title: A Randomized, Double-masked, Active-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Tedromer 5 mg Compared With Intravitreal Aflibercept 2 mg in Participants With Visual Impairment Secondary to Diabetic Macular Edema (DME) - ALTO

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

910

Start Date

2026-08-03

Completion Date

2029-09

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Tabirafusp tedromer

Intravitreal injection

DRUG

Aflibercept (2.0 mg)

Intravitreal injection

Locations (52)

Kodiak Research Center

Scottsdale, Arizona, United States

Kodiak Research Center

Bakersfield, California, United States

Kodiak Research Center

Glendale, California, United States

Kodiak Research Center

Modesto, California, United States

Kodiak Research Center

Oxnard, California, United States

Kodiak Research Center

Pasadena, California, United States

Kodiak Research Center

Redlands, California, United States

Kodiak Research Center

Redlands, California, United States

Kodiak Research Center

Sacramento, California, United States

Kodiak Research Center

Sacramento, California, United States

Kodiak Research Center

Waterford, Connecticut, United States

Kodiak Research Center

Fort Lauderdale, Florida, United States

Kodiak Research Center

St. Petersburg, Florida, United States

Kodiak Research Center

Winter Haven, Florida, United States

Kodiak Research Center

Elmhurst, Illinois, United States

Kodiak Research Center

Hagerstown, Maryland, United States

Kodiak Research Center

Saint Louis Park, Minnesota, United States

Kodiak Research Center

Madison, Mississippi, United States

Kodiak Research Center

Hauppauge, New York, United States

Kodiak Research Center

Rochester, New York, United States

Kodiak Research Center

Cary, North Carolina, United States

Kodiak Research Center

Greensboro, North Carolina, United States

Kodiak Research Center

Hickory, North Carolina, United States

Kodiak Research Center

Wake Forest, North Carolina, United States

Kodiak Research Center

Winston-Salem, North Carolina, United States

Kodiak Research Center

Beaufort, South Carolina, United States

Kodiak Research Center

Charleston, South Carolina, United States

Kodiak Research Center

Ladson, South Carolina, United States

Kodiak Research Center

Mt. Pleasant, South Carolina, United States

Kodiak Research Center

West Columbia, South Carolina, United States

Kodiak Research Center

Sioux Falls, South Dakota, United States

Kodiak Research Center

Amarillo, Texas, United States

Kodiak Research Center

Arlington, Texas, United States

Kodiak Research Center

Austin, Texas, United States

Kodiak Research Center

Bellaire, Texas, United States

Kodiak Research Center

Fort Worth, Texas, United States

Kodiak Research Center

Katy, Texas, United States

Kodiak Research Center

Plano, Texas, United States

Kodiak Research Center

Round Rock, Texas, United States

Kodiak Research Center

San Antonio, Texas, United States

Kodiak Research Center

Schertz, Texas, United States

Kodiak Research Center

The Woodlands, Texas, United States

Kodiak Research Center

Lynchburg, Virginia, United States

Kodiak Research Center

Bellevue, Washington, United States

Kodiak Research Center

Caba, Buenos Aires, Argentina

Kodiak Research Center

Caba, Buenos Aires, Argentina

Kodiak Research Center

Caba, Buenos Aires, Argentina

Kodiak Research Center

Caba, Buenos Aires, Argentina

Kodiak Research Center

Comodoro Rivadavia, Chubut Province, Argentina

Kodiak Research Center

Mendoza, Mendoza Province, Argentina

Kodiak Research Center

Rosario, Santa Fe Province, Argentina

Kodiak Research Center

Rosario, Santa Fe Province, Argentina