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NCT07734844
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
Conditions: Diabetic Macular Edema (DME)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 910
Sponsor: Kodiak Sciences Inc
Location: Kodiak Research Center Glendale California
Summary
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
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
Source: ClinicalTrials.gov (NCT07734844). StuddyBuddy aggregates publicly available trial information.
