Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
研究概览
简要总结
The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.
详细描述
The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.
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
- Double (Participant, Investigator)
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
- •Willing to give informed consent, make the required study visits and follow instructions;
- •Newly diagnosed with exudative age-related macular degeneration (AMD);
- •Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye);
- •Best-corrected visual acuity (BCVA) in study eye as specified in protocol;
- •No vision-threatening ocular condition other than AMD, in the opinion of the Investigator;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •History or current evidence of macular or retinal disease other than exudative AMD (study eye);
- •Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye);
- •Any evidence of vitreous hemorrhage (study eye);
- •History or evidence of surgery (study eye), as specified in protocol;
- •Any active systemic infection or ocular/intraocular infection or inflammation in either eye;
- •A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol;
- •History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study
- •History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator;
- •Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study;
- •Participation in any ocular or non-ocular investigational study within 30 days of screening;
- •Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-78898A
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
干预措施: AL-78898A (Drug)
Lucentis
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
时间窗: Week 4
The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Incidence of Events of Special Interest (ESI)
时间窗: Up to Day 30
An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.
次要结局
未报告次要终点