A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

CompletadoFase 3ClinicalTrials.gov

ID: NCT04432831Tipo: INTERVENTIONALInicio: 5 de ago de 2020Fin estimado: 11 de oct de 2023

Traducción no disponible, mostrando original

Resumen

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation
Ability to comply with the study protocol, in the investigator's judgment
For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Criterios de exclusión

Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab
Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
Requirement for continuous use of any medications or treatments indicated as prohibited therapy

Intervenciones

drug

Faricimab

Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.

other

Sham Procedure

The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Ubicaciones

Fundacion Zambrano

CABA, Argentina

Oftalmos

Capital Federal, Argentina

Oftar

Mendoza, Argentina

Centro Oftalmólogos Especialistas

Rosario, Argentina

Grupo Laser Vision

Rosario, Argentina

Organizacion Medica de Investigacion

San Nicolás, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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