A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 671
- 试验地点
- 1
- 主要终点
- Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12
研究概览
简要总结
This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.
The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.
详细描述
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
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, 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
- •Visual impairment predominantly due to neovascular age-related macular degeneration AMD
- •Active, newly diagnosed, untreated CNV due to AMD
- •CNV involving the center of the retina
- •A qualifying vision score at study entry
排除标准
- •Stroke or myocardial infarction less than 3 Months prior to study entry
- •Active injection or inflammation of either eye at the time of study entry
研究组 & 干预措施
RBZ 0.5 mg: VA only (Group I)
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
干预措施: Ranibizumab (Drug)
RBZ 0.5 mg: VA and/or OCT (Group II)
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12
时间窗: up to Month 12
Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.
次要结局
- Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12(up to Month 12)
- Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24(Baseline to Month 12 and 24)
- Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24(Baseline to Month 12 and 24)
- Dry Retina in the Study Eye on OCT at Month 12 and 24(Month 12 and 24)
- Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24(Baseline to Month 12 and 24)
- Treatment Patterns Over Time in Both Treatment Arms(Baseline to Month 12 and 24)
- Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time(Baseline to Month 12 and 24)
- Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time(Screening to Month 12 and 24)
- Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24(Month 12 and 24)
- Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye(Month 3 to Month 24)
- Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye(Baseline to Month 12 and 24)
- Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time(Baseline to Month 12 and 24)