drugset / Trial / NCT04603937

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

NCT04603937

Phase 3 Terminated 459 enrolled Kodiak Sciences Inc
RandomizedParallel-groupTriple-blindTreatment

Summary

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.

Timeline

Start
2020-09-30
Primary completion
2023-04-27
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 2 mg Intravitreal
Subject Tarcocimab tedromer Protein / enzyme biologic 5 mg Intravitreal