NCT02418754

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

A Phase 2, Double-Masked, Randomized, Controlled, Multiple-Dose, Regimen-Ranging Study of the Efficacy and Safety of Intravitreal REGN2176-3 in Patients With Neovascular Age-Related Macular Degeneration

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	REGN2176-3
DRUG	Intravitreal Aflibercept Injection (IAI)

Timeline

• Start date: 2015-05-05
• Primary completion: 2016-08-17
• Completion: 2017-04-03
• First posted: 2015-04-16
• Last updated: 2020-10-26
• Results posted: 2020-10-26

Locations

84 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study