EUCTR2008-007476-19-GB进行中（未招募）1 期
A prospective case series of Ranibizumab for the treatment of inflammatory and idiopathic choroidal neovascular membranes. - Ranibizumab for inflammatory choroidal neovascular membranes
niversity Hospitals Bristol NHS Trust0 个研究点目标入组 15 人开始时间: 2009年9月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
入选标准
- •inclusion criteria
- •Patients with newly presenting idiopathic and inflammatory choroidal neovascularisation
- •have a best-corrected log MAR visual acuity in the study eye between 73-24 letters
- •have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography:
- •-Evidence that CNV extends under the geometric centre of the foveal avascular zone
- •-The area of the CNV must occupy at least 50% of the total lesion.
- •-The lesion must be =5400 microns in greatest linear dimension (GLD)
- •-No subfoveal atrophic change, no subfoveal fibrosis. Area of fibrosis less than or equal to 50% of total lesion area.
- •-for occult with no classic CNV, the lesion must have presumed recent disease progression as assessed by the Investigator and defined as having at least one of the following criteria:
- •-Blood associated with the lesion at baseline
- •-=10% increase in the GLD as assessed by fluorescein angiography in the previous 3 months
- •-Loss of VA in the previous 3 months defined as either =5 letters logMAR vision as determined by protocol refraction and protocol measurement or 2 or more lines using a Snellen chart by standard examination
- •- Presence of subretinal fluid on OCT
- •Both male and female patients will be recruited and most of the patient are likely to be young. Most of the patients will be on oral steroids and systemic immunosuppression and that shall be continued at the discretion of treating ophthalmologist. The dose of these may be increased if the PSII was deemed to be uncontrolled but not just for treating the CNVM
- •Prior treatment with transpupillary thermotherapy (TTT), thermal laser, or verteporfin therapy (PDT) in the study eye
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0,
- •Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (Macugen® , Avastin® , anecortave acetate)
- •Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
- •History of vitrectomy surgery in the study eye
- •History of greater than mild non-proliferative diabetic retinopathy or any diabetic maculopathy
- •History of retinal vascular occlusions
- •History of glaucoma filtering surgery in the study eye
- •History of corneal transplant in the study eye
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
- •Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >50% of the total lesion area| or >1 disc areas in size
- •Subfoveal fibrosis or atrophy in the study eye. Area of fibrosis > 50% of total lesion area
- •CNV in either eye due to AMD
- •Retinal pigment epithelial tear involving the macula in the study eye
- •Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period
- •Current vitreous hemorrhage in the study eye
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Aphakia or absence of the posterior capsule in the study eye
- •Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
- •Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia or signs of pathologic myopia with a refraction of 4-8 diopters
- •For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed -8 diopters of myopia.
- •Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mmHg despite treatment with anti-glaucoma medication
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