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A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
Sponsor: Kodiak Sciences Inc
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
2026-08-21
Healthy Volunteers
No
Conditions
Interventions
Tabirafusp tedromer
Intravitreal injection
Aflibercept (2.0 mg)
Intravitreal injection
Locations (9)
Kodiak Research Center
Glendale, California, United States
Kodiak Research Center
Pasadena, California, United States
Kodiak Research Center
St. Petersburg, Florida, United States
Kodiak Research Center
Hagerstown, Maryland, United States
Kodiak Research Center
Saint Louis Park, Minnesota, 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
West Columbia, South Carolina, United States