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Not yet recruiting NCT07734844

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

Phase III Interventional Diabetic Macular Edema (DME)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tabirafusp tedromer, Aflibercept (2.0 mg).
Who it may be relevant to
Registry conditions: Diabetic Macular Edema (DME). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug Tabirafusp tedromer
    Intravitreal injection
  • Drug Aflibercept (2.0 mg)
    Intravitreal injection

Primary outcome measures

  • Best corrected visual acuity (BCVA) [Time frame: Week 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07734844 · KSMP002-S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗