EUCTR2011-004959-39-IE进行中（未招募）1 期
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
- 1 期
- 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
- •1. Written informed consent must be obtained before any study-related assessment is performed.
- •2. Male or female patients, =50 years of age.
- •Inclusion criteria for study eye
- •3. Visual impairment predominantly due to neovascular AMD
- •4. Active, newly diagnosed, angiographically documented CNV (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub RPE fluid on OCT) secondary to AMD in an eye previously untreated with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, transpupillary thermotherapy, submacular surgery, or any other surgical intervention for wAMD, any anti-VEGF compound or any investigational treatment, intravitreal or subtenon corticosteroid injection (within 90 days prior to screening) or device implantation
- •5. CNV or sequelae of the CNV (i.e., pigment epithelium detachment, subretinal or sub-RPE hemorrhage, blocked fluorescence, macular edema, or subretinal, sub-RPE or intraretinal fluid) involving the center of the fovea.
- •6. BCVA score at both Screening and Baseline between 78 and 23 letters inclusive (approximate Snellen equivalent of 20/32 and 20/320) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at 4 meters.
- •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 patient
- •1. Inability to comply with study or follow-up procedures.
- •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •3. 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.
- •Exclusion criteria for systemic medical history and conditions
- •4. Any type of systemic disease or its treatment, 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.
- •5. Stroke or myocardial infarction less than 3 months prior to Screening.
- •6. Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- •7. Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation, or fluorescein.
- •Exclusion criteria for ocular medical history and conditions
- •For either eye
- •8. Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of Screening or Baseline.
- •9. Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or according to investigator’s judgment) at the time of Screening or Baseline.
- •10. Neovascularization of the iris or neovascular glaucoma at the time of Screening or Baseline.
- •11. Inability to obtain optical coherence tomography (OCT) images of sufficient quality to be analyzed.
- •For study eye
- •12. 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 or Baseline.
- •13. 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 or Baseline that in the investigator’s opinion could substantially impact visual function improvement with treatment.
- •14. Atrophy or fibrosis involving the center of the fovea.
- •15. Total area of fibrosis comprising more than 50% of the lesion area.
- •Exclusion criteria for prior or current systemic medication
- •16. Use of other investigational drugs within 30 days or 5 half-lives from Baseline, whichever is longer.
- •17. Use of any systemic anti-VEGF drugs within 3 months prior to Baseline (e.g., bevacizumab [Avastin®]).
- •18. Use of systemic corticosteroids for at least 30 consecutive days within 3 months prior to screening.
- •19. Current or planned use of systemic medications known to be toxic to the lens, retina or
- •optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil®), tamoxifen, phenothiazines and ethambutol.
- •Exclusion criteria for prior or current ocular treatment
- •For fellow eye
- •20. 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
- •21. Any intraocular procedure (including Yttrium-Aluminum-Garnet capsu
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