drugset / Trial / NCT02418754

Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)

NCT02418754

Phase 2 Terminated 505 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy. The secondary objectives of the study were the following: * To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12) * To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI. * To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD

Timeline

Start
2015-05-05
Primary completion
2016-08-17
Completion
2017-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 2 mg Intravitreal
Subject RINUCUMAB Monoclonal antibody 1 mg Intravitreal
Subject RINUCUMAB Monoclonal antibody 3 mg Intravitreal