A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 144
- 试验地点
- 47
- 主要终点
- Percentage of Participants With Ocular Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study will be masked until database lock of the parent study (NCT03972709/GR40973). After the masked period, the study will follow an open-label design. The Outcome Assessor is masked for BCVA assessments.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation
- •Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging.
- •Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (BCVA) letter score is ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.
- •Ocular Inclusion Criteria: Non-Study Eye
- •The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.
排除标准
- •Ocular Exclusion Criteria:
- •Active uveitis and/or vitritis (grade trace or above) in either eye
- •Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment
- •Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye
- •Retinal pigment epithelium (RPE) tear that involves the macula in either eye
- •Moderate or severe non-proliferative diabetic retinopathy in either eye
- •Proliferative diabetic retinopathy in either eye
- •Central serous retinopathy in either eye
- •Recent history of recurrent infectious or inflammatory ocular disease in either eye
- •Recent history of idiopathic or autoimmune-associated uveitis in either eye
- •Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.
研究组 & 干预措施
Galegenimab 20 mg Q4W
Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).
干预措施: Galegenimab (Drug)
Galegenimab 20 mg Q8W
Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).
干预措施: Galegenimab (Drug)
Galegenimab 10 mg Q4W
Participants will receive 10 mg galegenimab via ITV injection Q4W.
干预措施: Galegenimab (Drug)
Galegenimab 10 mg Q8W
Participants will receive 10 mg galegenimab via ITV injection Q8W.
干预措施: Galegenimab (Drug)
结局指标
主要结局
Percentage of Participants With Ocular Adverse Events
时间窗: From baseline up to Week 104
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Percentage of Participants With Systemic (Non-Ocular) Adverse Events
时间窗: From Baseline up to Week 104
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
次要结局
未报告次要终点