A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 372
- 试验地点
- 71
- 主要终点
- Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)
研究概览
简要总结
This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age >/= 60 years at time of signing Informed Consent Form;
- •Visual acuity: best-corrected visual acuity (BCVA) letter score >/= 24 letters (Snellen equivalent of 20/320 or better). If the study eye 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);
- •Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.
排除标准
- •Ocular Exclusion Criteria, Study Eye:
- •History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD;
- •Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.
- •Ocular Exclusion Criteria, Both Eyes:
- •GA in either eye due to causes other than AMD;
- •Active uveitis and/or vitritis (grade trace or above) in either eye;
- •Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye;
- •Retinal pigment epithelium (RPE) tear that involves the macula in either eye;
- •Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.
研究组 & 干预措施
Galegenimab Q4W
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
干预措施: Galegenimab (Drug)
Sham Control Q4W
Participants will receive Sham-control Q4W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
干预措施: Sham Control (Drug)
Galegenimab Q8W
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
干预措施: Galegenimab (Drug)
Sham Control Q8W
Participants will receive Sham-control Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
干预措施: Sham Control (Drug)
结局指标
主要结局
Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)
时间窗: Baseline, Week 72
GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in central visual acuity occurs with a decline in activities of daily living. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
次要结局
- Percentage of Participants With Ocular Adverse Events in the Study Eye(From baseline to Week 76)
- Percentage of Participants With Ocular Adverse Events in the Fellow Eye(From baseline to Week 76)
- Percentage of Participants With Systemic Adverse Events(From baseline to Week 76)
- Percentage of Participants With Serious Adverse Events (SAEs)(From baseline to Week 76)
- Percentage of Participants With Adverse Events of Special Interest (AESIs)(From baseline to Week 76)
- Percentage of Participants With Adverse Events Leading to Study Discontinuation(From baseline to Week 76)
- Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions(Baseline, Week 72)
- Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart(Baseline, Week 72)