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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKodiak Sciences Inc

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tabirafusp tedromer
  • Aflibercept (2.0 mg)

Treatment groups

910 Participants
are divided into 3 treatment groups

Sponsors and collaborators