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NCT07734844PHASE3Recruiting

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

Kodiak Sciences Inc

Start Date

8/3/2026

Completion Date

9/1/2029

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * DME, treatment-naïve or previously-treated * Male or female ≥18 years of age with Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12% * Capable of giving informed signed consent Exclusion Criteria: * Active iris or angle neovascularization or neovascular glaucoma in the Study Eye. * Current or history of retinal detachment (tractional or rhegmatogenous) in the Study Eye

Interventions

DRUG

Tabirafusp tedromer

DRUG

Aflibercept (2.0 mg)

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Conditions

Diabetic Macular Edema (DME)

Locations

Kodiak Research Center

Glendale, California 91204

United States

Kodiak Research Center

Pasadena, California 91107

United States

Kodiak Research Center

St. Petersburg, Florida 33711

United States

Kodiak Research Center

Hagerstown, Maryland 21740

United States

Kodiak Research Center

Saint Louis Park, Minnesota 55416

United States

Kodiak Research Center

Beaufort, South Carolina 29902

United States

Kodiak Research Center

Charleston, South Carolina 29414

United States

Kodiak Research Center

Ladson, South Carolina 29456

United States

Kodiak Research Center

West Columbia, South Carolina 29169

United States