NL-OMON50774已完成3 期
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION - AVONELLE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Previous enrollment in and completion of Study GR40306 (TENAYA) or Study
- •GR40844 (LUCERNE), without study or study drug discontinuation
- •For women of childbearing potential: agreement to remain abstinent or use
- •contraception, and agreement to refrain from donating eggs. Women must remain
- •abstinent or use contraceptive methods with a failure rate of < 1% per year
- •during the treatment period and for 3 months after the final dose of faricimab.
- •Women must refrain from donating eggs during the same period.
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study
- •or within 28 days after the final dose 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-related procedure preparations, 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
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate long-term safety and tolerability of lampalizumab intravitreal injections in patients with geographic atrophy secondary to age-related macular degeneration (Omaspect)Geographic Atrophy secondary to age-related macular degenerationMedDRA version: 20.0Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 100000004853EUCTR2016-000423-13-NLF. Hoffmann-La Roche Ltd1,800
进行中（未招募）
1 期
A Study to Evaluate Long-Term Safety and Tolerability of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration (Portal)EUCTR2020-004427-16-ATF. Hoffman-La Roche Ltd1,035
进行中（未招募）
1 期
A study to evaluate long-term safety and tolerability of lampalizumab intravitreal injections in patients with geographic atrophy secondary to age-related macular degeneration (Omaspect)EUCTR2016-000423-13-DEF. Hoffmann-La Roche Ltd1,800
进行中（未招募）
1 期
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients with Diabetic Macular EdemaEUCTR2020-000402-29-CZF.Hoffmann La-Roche Ltd1,800
进行中（未招募）
1 期
A study to evaluate long-term safety and tolerability of lampalizumab intravitreal injections in patients with geographic atrophy secondary to age-related macular degeneration (Omaspect)Geographic Atrophy secondary to age-related macular degenerationMedDRA version: 19.0 Level: LLT Classification code 10063947 Term: Geographic atrophy System Organ Class: 100000004853EUCTR2016-000423-13-PTF. Hoffmann-La Roche Ltd842