High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia [HD-LIPT]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Visual Acuity Change From Baseline to Month 12 of the Study
研究概览
简要总结
Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia (MacTel)] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always symmetric disorder. It is characterized in its early stages by dilation and loss of parafoveal capillaries accompanied by angiographic leakage, "right angle" venules, central and parafoveal intraretinal cysts.
详细描述
DESCRIPTION OF THE STUDY
This is an open-label, Phase I/II study of intravitreally administered ranibizumab in subjects with nonproliferative Idiopathic Parafoveal Telangiectasia (IPT).
Consented, enrolled subjects will be randomized into two groups: observation and treatment. The observation group will be monitored monthly while the treatment group will receive three open-label intravitreal injections of 1.0 mg ranibizumab administered every 30 days for 3 months and then as needed monthly, based on defined criteria. NOTE: The original protocol had the treatment group dosed at 2.0 mg/0.05mL. However, the 2.0mg dose will become unavailable beginning January 31, 2012. Therefore, the protocol amendment submitted in December 2011 changed the 2.0mg arm to a 1.0mg/ 0.10mL arm. Please note that three patients were already treated with 2.0mg before the amendment was submitted, so they will be switched to 1.0mg if they have not completed the study when the 2.0 dose is no longer available in January 2012.
Protocol: FVF4875s Final 6/P
29MAR2010
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
- 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
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 18 years
- •Presence of nonproliferative IPT confirmed by fluorescein angiography and spectral-domain OCT
- •Age greater than 18
- •Vision equal to or worse than 20/25 and better than or equal to 20/400 by ETDRS chart, without co-existing choroidal neovascularization.
- •Physical ability and reasonable expectation to maintain all follow-up appointments.
排除标准
- •Pregnancy (positive pregnancy test) or lactation
- •Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous ophthalmologic investigation or trial
- •Any patient with proliferative diabetic retinopathy, diabetic macular edema, uveitis, history of ocular trauma, severe glaucoma, neovascular age-related macular degeneration
- •Duration of previous treatment of IPT that exceeds two years.
- •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 12-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 (BCVA) over the study period
- •Prior/Concomitant Treatment:
- •Previous steroids (oral) within 30 days preceding Day 0
- •Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
- •Prior participation in a Genentech ranibizumab clinical trial within 60 days.
- •History of receiving intravitreal injections of ranibizumab, bevacizumab, pegaptanib, or any other intravitreal medication within 60 days of first injection. History of receiving intravitreal or subtenons triamcinolone within 90 days of first injection.
研究组 & 干预措施
Intravitreal ranibizumab 2.0mg
Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
干预措施: ranibizumab 2.0mg (Drug)
结局指标
主要结局
Visual Acuity Change From Baseline to Month 12 of the Study
时间窗: Baseline to 12 months
次要结局
- Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months(Baseline to 6 months and baseline to 9 months)
- Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months(Baseline to 6, 9, and 12 months)
- Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg(Baseline to 6 month, baseline to 9 month and baseline to 12 months)
- Angiographic Leakage From Baseline to Month 6 and 12(Baseline to 6 and baseline to 12 months)
研究者
Arthur Korotkin, M.D.
M.D.
Eye Center of Northern Colorado, P.C.