EUCTR2011-004959-39-IT进行中（未招募）不适用
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 (OCTAVE) - OCTAVE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for patient
- •- Male or female patients, =50 years of age.
- •Inclusion criteria for study eye
- •- Visual impairment predominantly due to neovascular AMD
- •- Active, newly diagnosed, untreated, angiographically documented, CNV lesion secondary to AMD
- •- CNV or sequelae of the CNV involving the center of the fovea.
- •- The total area of fibrosis comprising less than 50% of the lesion area.
- •- BCVA score at both Screening and Baseline between 78 and 23 letters as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at 4 meters, inclusively (approximate Snellen equivalent of 20/32 and 20/320).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •Exclusion criteria for systemic medical history and conditions
- •- Stroke or myocardial infarction less than 3 months prior to Screening.
- •Exclusion criteria for ocular medical history and conditions
- •For either eye
- •- Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of Screening or Baseline.
- •- Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or according to investigator’s judgment) at the time of Screening or Baseline.
- •For study eye
- •- Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wet AMD (e.g., ocular histoplasmosis, pathologic myopia) at the time of Screening and Baseline.
- •- Irreversible structural damage within 0.5 disc diameter of the center of the macula (e.g., vitreomacular traction, epiretinal membrane, scar, laser burn, macular hole) at the time of Screening and Baseline that in the investigator’s opinion could preclude visual function improvement with treatment.
- •Exclusion criteria for prior or current ocular treatment
- •For either eye
- •- Treatment with any anti-angiogenic drugs (including any anti-VEGF agents) within 3 months prior to Baseline in either eye (e.g., bevacizumab [Avastin®]).
- •For study eye
- •- Any intraocular procedure (including Yttrium-Aluminum-Garnet capsulotomy) within 2 months prior to Baseline or anticipated within the next 6 months following Baseline.
研究者
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