EUCTR2020-000402-29-CZ进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
- •- 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 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
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: 19.0Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 100000004853EUCTR2016-000423-13-HUF. Hoffmann-La Roche Ltd1,800