A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF LAMPALIZUMAB IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULARDEGENERATION WHO HAVE COMPLETED A ROCHE-SPONSORED STUDY

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 1 人开始时间: 2017年3月2日最近更新: 2023年9月4日

适应症

试验速览

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•Previous enrollment in and completion of study treatment and the Week 96 visit of either
•Study GX29185 or Study GX29176, without early treatment discontinuation (lampalizumab or sham).
•Willingness and ability to provide signed informed consent.
•Willingness and ability to undertake all scheduled visits and assessments.
•For women who has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), or has not undergone surgical sterilization: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 30 days after the last dose of lampalizumab.
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 120 days after the last dose of study drug. Men must refrain from donating sperm during this same time period.

•History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
•History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications.
•Predisposition to or history of increased risk of infection (e.g., history of splenectomy or chronic immunosuppression).
•Requirement for continuous use of any medications or treatments indicated in the Excluded Therapy” section of the protocol.
•Pregnancy or lactation, or intention to become pregnant during the study.

发起方