A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

TerminadoFase 3ClinicalTrials.gov

ID: NCT02247531Tipo: INTERVENTIONALInicio: 6 de oct de 2014Fin estimado: 23 de ene de 2018

Traducción no disponible, mostrando original

Resumen

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Participants aged greater than or equal to (\>/=) 50 years
Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Criterios de exclusión

History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)
GA in either eye due to causes other than AMD
Previous treatment with eculizumab, lampalizumab, and/or fenretinide

Intervenciones

drug

Lampalizumab

10 mg dose of lampalizumab administered intravitreally.

other

Sham Comparator

A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

Ubicaciones

Oftalmos

Capital Federal, Argentina

Instituto de la Vision

Capital Federal, Argentina

Hospital El Cruce

San Juan Bautista, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase III, Multicenter, Randomized, Double-Masked, Sham... | EligiMed