A 12-month, Phase 3b, Randomized, Visual Acuity Assessor-masked, Multicenter Study Assessing the Efficacy and Safety of Ranibizumab 0.5mg in Treat and Extend Regimen Compared to Monthly Regimen, 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
- 650
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12
研究概览
简要总结
This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration
详细描述
This was a 12-month, phase IIIb, randomized, Visual Acuity assessor-masked, multi-center, interventional study assessing the efficacy and safety of the TER vs monthly regimens of 0.5 mg ranibizumab intravitreal (IVT) injections in patients with newly diagnosed nAMD. Patients will be randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens.
There will be 3 periods in this study: Screening period (up to 14days), treatment period (11 months), follow-up period (1 month). At randomization visit patients will be randomized into one of the 2 treatment groups Group I ranibizumab 0.5 mg based on monthly treatment or Group II ranibizumab 0.5 mg based on TER (randomization ratio of 1:1) and will receive the first dose of Investigational treatment. Patients in Group I the following visits will perform on monthly intervals. For patients in Group II the investigator will evaluate disease activity (i.e., signs of exudation) based on SD-OCT, and in case of absence of disease activity every next visit will be 2 weeks), with a maximum of a 12-week interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Male or female patients, ≥50 years of age with signed informed consent before study procedures
- •Visual impairment predominantly due to nAMD.
- •Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography
- •Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT
- •BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320)
排除标准
- •Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
- •Stroke or myocardial infarction within 3 months prior to Screening.
- •Any active periocular or ocular infection or inflammation in both eyes.
- •Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity.
- •Presence of amblyopia or amaurosis in the fellow eye.
- •History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye.
- •History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening.
- •Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
研究组 & 干预措施
Group I ranibizumab 0.5 mg monthly
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) up to month 11
干预措施: Ranibizumab 0.5mg (Drug)
Group II ranibizumab 0.5 mg TER
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen up to month 11
干预措施: Ranibizumab 0.5mg (Drug)
结局指标
主要结局
Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12
时间窗: Baseline to month 12
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
次要结局
- The Mean Number of Treatment Frequency(Month 12)
- The Average Number of Days Between Injections(Month 12)
- Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12(Baseline and every month for 12 months)
- Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit(Baseline and every month for 12 months)
- Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12(Baseline and every month for 12 months)
- Number of Visits Scheduled(From Month1 to Month 11)
- Change in BCVA From Baseline to Month 12(Baseline to Month 12)
- Average BCVA Change From Baseline to Month 12(Baseline and every month for 12 months)
- Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12(Baseline and every month for 12 months)
- Percentage of Participants With Fluid Free Macula Over Time up to Month 12(Month 12)
- Change in Central Subfield Retinal Thickness (CSFT) Over Time(Month 12)
- Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at(Month 12)
- Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)(Baseline, Month 12)