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

NCT07734844 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 910

Last updated 2026-08-21

No results posted yet for this study

Summary

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

Conditions

  • Diabetic Macular Edema (DME)

Interventions

DRUG

Tabirafusp tedromer

Intravitreal injection

DRUG

Aflibercept (2.0 mg)

Intravitreal injection

Sponsors & Collaborators

  • Kodiak Sciences Inc

    lead INDUSTRY

Principal Investigators

  • J. Pablo Velazquez-Martin, MD · Kodiak Sciences Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2028-08-31
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734844 on ClinicalTrials.gov