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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetic Macular Edema (DME)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kodiak Research Center, Glendale, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tabirafusp tedromer

Drug

Intravitreal injection

Other names: KSI-501

Aflibercept (2.0 mg)

Drug

Intravitreal injection

Other names: Eylea

Primary outcomes

Best corrected visual acuity (BCVA)

Time frame: Week 52

Mean change in BCVA from Day 1 to Year 1

Study contacts

Contact information is provided by the study sponsor or research team.

Kodiak Sciences Inc

CONTACT

[email protected]

6502810850

Sponsors and collaborators

Lead sponsor

Kodiak Sciences Inc

Industry

Registry information

Official study 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

Acronym: ALTO

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jul 29, 2026
Registry last updated: Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting