Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 119
- 主要终点
- Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
研究概览
简要总结
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Geographic atrophy in both eyes due to age-related macular degeneration
- •Visual acuity between 20/40 to 20/320
排除标准
- •Known allergy to brimonidine
- •Uncontrolled systemic disease or infection of the eye
- •Recent eye surgery or injections in the eye
- •Female patients who are pregnant, nursing or planning a pregnancy
研究组 & 干预措施
400 µg Brimonidine Tartrate Implant Stage 1
Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: 400 µg Brimonidine Tartrate Implant (Drug)
400 µg Brimonidine Tartrate Implant Stage 1
Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: Sham (no implant) (Other)
200 µg Brimonidine Tartrate Implant Stage 1
Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: 200 µg Brimonidine Tartrate Implant (Drug)
200 µg Brimonidine Tartrate Implant Stage 1
Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: Sham (no implant) (Other)
400 µg Brimonidine Tartrate Implant Stage 2
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: 400 µg Brimonidine Tartrate Implant (Drug)
400 µg Brimonidine Tartrate Implant Stage 2
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: Sham (no implant) (Other)
200 µg Brimonidine Tartrate Implant Stage 2
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: 200 µg Brimonidine Tartrate Implant (Drug)
200 µg Brimonidine Tartrate Implant Stage 2
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
干预措施: Sham (no implant) (Other)
Sham (no implant) Stage 2
Stage 2: sham in both eyes on Day 1 and Month 6.
干预措施: Sham (no implant) (Other)
结局指标
主要结局
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
时间窗: Baseline, Month 12
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm\^2).
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, 24 Months)
- Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye(Baseline, Month 3, Month 6, Month 9, Month 18, Month 24)
- Change From Baseline in Contrast Sensitivity in the Study Eye(Baseline, 24 Months)
- Change From Baseline in Reading Speed in the Study Eye(Baseline, 24 Months)