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临床试验/NCT00378196
NCT00378196已完成1 期

Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters

研究概览

简要总结

This research is being done to look at the effects of an experimental drug, ranibizumab, for the treatment of a condition called "idiopathic parafoveal telangiectasia" or IPT. IPT is caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to leaky blood vessels in this area. Swelling in the retina can lead to blurry vision.

详细描述

This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab. Patients with IPT with macular edema documented on optical coherence tomography (OCT) but no choroidal neovascularization will be eligible for this study. Exclusion criteria will include other forms of retinopathy, active intraocular inflammation, history of poor vision due to conditions other than IPT in either eye, and known hypersensitivity to humanized monoclonal antibodies.

After obtaining informed consent, the patient will undergo baseline assessment including best-corrected Early Treatment for Diabetic Retinopathy Study (ETDRS) visual acuity, ocular examination, color fundus photography, fluorescein angiography, and OCT. If both eyes are eligible, the study participant and investigator will choose which eye to be considered the study eye. The study eye will be assigned at random to receive an intravitreal dose of ranibizumab (0.3 mg/0.05 ml or 0.5 mg/0.05 ml) at the baseline, 1 month, and 2 month visits. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness <225 microns).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will be eligible if the following criteria are met:
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age > 18 years
  • Diagnosis of bilateral IPT with macular edema documented on OCT and no evidence of choroidal neovascularization.
  • Best corrected visual acuity of better or equal to 20/200 in both eye

排除标准

  • Subjects who meet any of the following criteria will be excluded from this study:
  • Known hypersensitivity to humanized monoclonal antibodies
  • History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
  • History of stroke within 6 months of study entry.
  • Current acute ocular or periocular infection.
  • Any major surgical procedure within one month of study entry.
  • Known serious allergies to fluorescein dye.
  • Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
  • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
  • History of subfoveal laser treatment in the study eye.
  • History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than IPT in the study eye.
  • Ocular inflammation (including trace or above) in the study eye.
  • Inability to comply with study or follow up procedures.

研究组 & 干预措施

A

Experimental

0.3 mg/0.05 ml dose of ranibizumab

干预措施: Ranibizumab (Drug)

B

Experimental

0.5 mg /0.05 ml dose of ranibizumab

干预措施: Ranibizumab (Drug)

结局指标

主要结局

Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters

时间窗: 3 months

次要结局

  • Retinal changes on ophthalmoscopy(3 months)
  • Retinal thickness measured by Optical Coherence Topography (OCT)(3 months)
  • Fluorescein leakage on fluorescein angiography(3 months)
  • Complications related to drug or its administration(12 months after last injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Neil M. Bressler

Principal Investigator

Johns Hopkins University

研究点 (1)

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