A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 36
- 主要终点
- Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
研究概览
简要总结
This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.
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
- •Complement Factor I (CFI) profile biomarker-positive result
- •Women of child bearing potential and men should remain abstinent or use contraceptive methods
排除标准
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
- •Previous subfoveal focal laser photocoagulation in study eye
- •Laser photocoagulation in the study eye
- •Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
- •Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
- •Previous cell-based intraocular treatment in study eye
- •Intraocular surgery in study eye
- •Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
- •History of corneal transplant in study eye
- •GA in either eye due to causes other than AMD
- •Proliferative diabetic retinopathy in either eye
- •Active or history of neovascular (wet) AMD in either eye
- •History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
- •Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
- •Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle
- •Previous expression vector mediated intraocular treatments
- •Uncontrolled blood pressure and atrial fibrillation
- •Medical conditions associated with clinically significant risk for bleeding-
- •Predisposition or history of increased risk for infection
- •Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (>/=) 12 months
- •History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection
- •Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment
- •Previous participation in other studies of investigational drugs
研究组 & 干预措施
Lampalizumab: Open-label Safety Run-In
Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.
干预措施: Lampalizumab (Drug)
Q2W Lampalizumab: Randomized Treatment
Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.
干预措施: Lampalizumab (Drug)
Q4W Lampalizumab: Randomized Treatment
Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.
干预措施: Lampalizumab (Drug)
Sham: Randomized Treatment
Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.
干预措施: Sham (Other)
结局指标
主要结局
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
时间窗: Baseline, Week 24
GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. 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 geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
次要结局
- Serum Concentrations of Lampalizumab (Q2W)(Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose)
- Serum Concentrations of Lampalizumab (Q4W)(Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination)
- Percentage of Participants With Anti-Lampalizumab Antibodies(Baseline up to approximately 30 weeks)
- Percentage of Participants With Ocular Adverse Events (AEs)(Baseline up to approximately 30 weeks)
- Percentage of Participants With Systemic (Non-ocular) Adverse Events(Baseline up to approximately 30 weeks)