A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA

F.Hoffmann La-Roche Ltd0 个研究点目标入组 1,800 人开始时间: 2020年6月2日最近更新: 2023年11月20日

适应症

试验速览

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•- Previous enrollment in and completion of Study GR40349 (YOSEMITE) or GR40398 (RHINE), without study or study drug discontinuation
•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 900
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 900

•- Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days 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
•- Requirement for continuous use of any medications or treatments indicated as prohibited therapy

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