A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

Clinical trials information0 个研究点目标入组 750 人开始时间: 2021年3月31日最近更新: 2023年10月17日

研究概览

暂无简介。

•Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), diagnosed no longer than 4 months prior to the screening visit
•-Signed Informed Consent Form
•-Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
•-Ability to comply with the study protocol, in the investigator's judgment
•-For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment

•-Any major illness or major surgical procedure within 1 month before screening
•-Uncontrolled blood pressure
•-Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
•-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
•-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

发起方

Clinical trials information