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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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

What is being tested

Tabirafusp tedromer (drug)
Aflibercept (2.0 mg) (drug)

Sponsor: Kodiak Sciences Inc · Participants: 910 · Started: Aug 3, 2026

Contact the study team

Kodiak Sciences Inc · Phone: 6502810850

Official record on ClinicalTrials.gov — NCT07734844

Locations in the U.S.

California	Kodiak Research Center, Glendale Kodiak Research Center, Pasadena
Florida	Kodiak Research Center, St. Petersburg
Maryland	Kodiak Research Center, Hagerstown
Minnesota	Kodiak Research Center, Saint Louis Park
South Carolina	Kodiak Research Center, Beaufort Kodiak Research Center, Charleston Kodiak Research Center, Ladson Kodiak Research Center, West Columbia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.