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REGN2176-3 · CAPELLA

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

Ensayo de REGENERON PHARMACEUTICALS, INC. en Degeneracion macular asociada a la edad neovascular.

Más ensayos de: Degeneración macular asociada a la edad neovascular.

Fase

Fase 2

Estado

Interrumpido

Participantes

505

previstos

Centros

84

Fin del objetivo primario

ago 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en may 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «No additional efficacy seen with REGN2176-3 over aflibercept alone».

Qué mide

Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12 (del registro, en inglés) (inicio y semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02418754), actualizada en oct 2020.