A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)

CompletadoFase 3ClinicalTrials.gov

ID: NCT03823300Tipo: INTERVENTIONALInicio: 11 de mar de 2019Fin estimado: 7 de ene de 2022

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
Ability to comply with the study protocol, in the investigator's judgment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Criterios de exclusión

Uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while a patient is at rest on Day 1
Pregnancy or breastfeeding, or intention to become pregnant during the study
CNV due to causes other than AMD in the study eye
Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
Uncontrolled glaucoma in the study eye
Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
Prior IVT administration of faricimab in either eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active ocular inflammation or suspected or active ocular or periocular infection in either eye

Intervenciones

drug

Faricimab

Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.

drug

Aflibercept

Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).

procedure

Sham Procedure

The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.

Ubicaciones

Organizacion Medica de Investigacion

Buenos Aires, Argentina

Fundacion Zambrano

CABA, Argentina

Centro Oftalmológico Dr. Charles S.A.

Capital Federal, Argentina

Oftalmos

Capital Federal, Argentina

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, Argentina

Oftar

Mendoza, Argentina

Grupo Laser Vision

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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