EUCTR2011-004959-39-SK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
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. 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.
- 另有 11 项未显示
研究者
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