NCT00470678已完成3 期
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5 mg) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration Over 12 Months
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Mean change in best-corrected visual acuity (BCVA) from Baseline, Month 4 and Month 12 as assessed with ETDRS (Early Treatment for Diabetic Retinopathy Study)-like charts at a distance of four meters
研究概览
简要总结
This study will evaluate efficacy and safety for monthly ranibizumab 0.5 mg intravitreal injections in Asian patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 Asian patients 50 years of age or greater.
- •Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or active occult lesions with no classic component.
- •Patients who have a BCVA score between 73 and 24 letters (approximately 20/40 to 20/320 Snellen equivalent), inclusively, in the study eye.
- •Total area of CNV (including both classic and occult components) encompassed within the lesion must be >= 50% of the total lesion area
- •Total lesion area must be <= 12 disc areas
排除标准
- •Patients who have in the fellow eye a Snellen equivalent below 20/200
- •Presence of angioid streaks, presumed ocular histoplasmosis syndrome, myopia (exceeding -8 diopters), or CNV secondary to causes other than AMD in the study eye
- •Subfoveal fibrosis or atrophy in the study eye
- •Total area of CNV (including both classic and occult components) encompassed within the lesion must be >= 50% of the total lesion area
- •Total lesion area must be <= 12 disc areas
- •Vitreous hemorrhage, retinal tear or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
- •Active, or history of, ocular inflammation or infection in the study eye within the last 30 days prior to screening.
- •Uncontrolled glaucoma in the study eye
- •Treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy within 30 days prior to screening
- •Previous treatment with anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, corticosteroids, protein kinase C inhibitors, squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD in the study eye. Treatment of the fellow eye is permitted if administered > 30 days before screening.
- •History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery more than 60 days prior to screening
- •History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
研究组 & 干预措施
1
Experimental
Ranibizumab
干预措施: ranibizumab (Drug)
结局指标
主要结局
Mean change in best-corrected visual acuity (BCVA) from Baseline, Month 4 and Month 12 as assessed with ETDRS (Early Treatment for Diabetic Retinopathy Study)-like charts at a distance of four meters
时间窗: Baseline, Month 4 and Month 12
次要结局
- Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4 and Month 12(Month 4 and Month 12)
- Safety by rates of adverse events and serious adverse events, ophthalmic examinations, tonometry, and vital signs, baseline, Month 4, Month 6 and Month 12(Baseline, Month 4, Month 6 and Month 12)
研究者
研究点 (2)
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