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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07734844

Acronym

ALTO

Enrollment

910

Registered

2026-07-29

Start date

2026-08-03

Completion date

2029-09-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema (DME)

Keywords

DME, KSI-501, tabirafusp tedromer, aflibercept, antibody biopolymer conjugate, anti-VEGF, anti-IL-6, Kodiak Sciences

Brief summary

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

Interventions

DRUGTabirafusp tedromer

Intravitreal injection

DRUGAflibercept (2.0 mg)

Intravitreal injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Participants will be randomized 5:3:5 into one of three treatment groups: tabirafusp-ted Q8W; tabirafusp-ted Q4-24W; or aflibercept.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Best corrected visual acuity (BCVA)	Week 52	Mean change in BCVA from Day 1 to Year 1

Countries

United States

Contacts

CONTACTKodiak Sciences Inc

ClinicalTrials@kodiak.com6502810850

STUDY_DIRECTORJ. Pablo Velazquez-Martin, MD

Kodiak Sciences Inc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026