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)
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