drugset
drugset / Trial / NCT00789477

DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

NCT00789477 ↗

Phase 2 Completed 221 enrolled Regeneron Pharmaceuticals Bayer · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Timeline

Start
2008-12
Primary completion
2009-12
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 0.5 mg Intravitreal
Subject Aflibercept Protein / enzyme biologic 2 mg Intravitreal

Indications

diabetic macular edema