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

NCT07734844 · tracked via the Priya Life Science USA tracker

Sponsor

Kodiak Sciences Inc

Phase

Phase 3

Started

2026-08-03

Last updated

2026-08-21

Condition(s) studied

Diabetic Macular Edema (DME)

Investigational drug(s) / intervention(s)

Tabirafusp tedromerAflibercept (2.0 mg)

Tabirafusp tedromer: Intravitreal injection

Aflibercept (2.0 mg): Intravitreal injection

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Best corrected visual acuity (BCVA) — Week 52
Mean change in BCVA from Day 1 to Year 1

Trial sites (9)

Facility	City	Region	Status
Kodiak Research Center	Glendale	California	Recruiting
Kodiak Research Center	Pasadena	California	Recruiting
Kodiak Research Center	St. Petersburg	Florida	Recruiting
Kodiak Research Center	Hagerstown	Maryland	Recruiting
Kodiak Research Center	Saint Louis Park	Minnesota	Recruiting
Kodiak Research Center	Beaufort	South Carolina	Recruiting
Kodiak Research Center	Charleston	South Carolina	Recruiting
Kodiak Research Center	Ladson	South Carolina	Recruiting
Kodiak Research Center	West Columbia	South Carolina	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07734844 on ClinicalTrials.gov ↗ ← All trials in the USA