NCT00102115终止1 期
Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease
Light Sciences LLC2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2004年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).
详细描述
This Phase 1 study is a safety and tolerability investigation of LS11 photodynamic therapy in subjects with persistent leaking neovascular membranes in patients with AMD who have a visual acuity of 20/200 or less. This is a sequential group dose escalation trial with the cohorts defined by increasing the light dose. Within each light-dose cohort, three (3) subjects will be treated at a drug dose of 0.2 mg/kg or 0.5 mg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 or older
- •Subject is able to sign informed consent
- •Ability to complete 6 month trial
- •Present with advanced AMD and persistently leaking CNV
- •Adequate hematologic, renal and liver function
- •Negative pregnancy test
- •Subject is able to safely undertake all protocol directed instructions
- •Visual acuity of 20/200 (logMAR 1.0)(6/60) or worse
排除标准
- •Concomitant eye disease in eye to be treated
- •Prior ocular radionuclide treatments
- •Known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish
- •History of investigational drug or therapy including biologics within 30 days prior to the study drug dosing
- •Women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions
- •History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum
- •History of clinically significant cardiovascular abnormalities, including myocardial infarction in the past 6 months, uncontrolled arrhythmias, uncontrolled congestive heart failure
- •Concomitant use of other drugs known to produce skin photosensitivity, e.g. tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics and griseofulvin, St. John's Wort
- •Subjects with high or pathological myopia with an axial length > 26mm or a refractive error of >/= -8.00D
- •Subjects with glaucoma and vision loss in either eye
- •Subject with a history of other choroidal leakage, e.g. histoplasmosis
- •Subjects with significant media opacity
- •Subjects diagnosed with diabetic retinopathy
- •Subjects who have had eye surgery within the past 3 months
- •Subjects who have received PDT treatment for AMD in the treatment eye
- •Any disease or condition that the sponsor or the investigator believes will impact the subject's ability to adhere to the study schedule
- •Subjects participating in any concurrent trial
结局指标
主要结局
Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
次要结局
- Changes in visual performance
研究者
研究点 (2)
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