A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia
详细描述
This is a Prospective Interventional, non-comparative study in 20 consecutive patients who will be selected from the outpatient services. After taking an informed consent, the patients will be given intravitreal Pegaptanib 0.3 mg every 6 weeks for 3 procedure of injection. Thereafter, patients will continue to be examined every 6 weeks (± 2 weeks) and of may receive additional injections as needed based on the presence of one or more re-treatment criteria (please see below). Final assessment will be done at 54 weeks and all the baseline investigations will be performed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Should be willing to participate in the trial.
- •Age less than 55 years.
- •Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart.
- •Myopia of ≥ 6 Diopters.
- •Fluorescein angiographic documentation of CNV.
排除标准
- •Ocular causes, or other ocular disorders leading to vision loss.
- •Maculopathy not related to pathologic myopia.
- •Pregnancy, lactation.
- •Not willing to provide an informed consent.
- •History of previous macular laser including PDT.
- •Other forms of therapy including intravitreal injections.
- •History of intraocular surgery in the past 3 months.
- •Anticipated cataract surgery in the next 6 months.
- •Any active infection or inflammation in the eye.
- •Cases where good quality imaging is not possible, either due to hazy media or extremely high myopia.
- •Patients with uncontrolled glaucoma, with IOP > 21mm Hg on 2 or more medications.
- •Patients with subfoveal scar or significant subretinal haemorrhage occupying more than 50% of lesion size.
- •Eyes with previous retinal detachment.
研究组 & 干预措施
Intravitreal Pegaptanib
干预措施: Intravitreal Pegaptanib (Drug)
结局指标
主要结局
Visual Acuity
时间窗: 12 months
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
次要结局
- Mean change in macular thickness on OCT from baseline to 54 weeks(12 months)
研究者
Raja Narayanan
Head of Clinical Research
L.V. Prasad Eye Institute