NCT01423149已完成2 期
A Phase II, Dose Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating Subfoveal Choroidal Neovascularization in Subjects With Pathologic Myopia
Mateon Therapeutics0 个研究点目标入组 23 人开始时间: 2005年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- Visual acuity line change from baseline at 3-month following
研究概览
简要总结
The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27, 36 and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal neovascularization in subjects with pathologic myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Be able and willing to follow instructions
- •Age 18 to 50 years old (inclusive)
- •Have area of CNV within 50 um or under the geometric center of the foveal avascular zone Have greatest linear dimension of lesion 5,400 um or less, with >/=50.0% of the lesion composed of CNV (features which obscure the boundaries of the CNV such as blood, serous pigment epithelial detachment or blocked fluorescence must occupy <50.0%) as confirmed by Doheny Image Reading Center (DIRC)
- •Have best corrected distance visual acuity (ETDRS) of 20/20 to 20/200 (LogMAR +0.0 to 1.0), inclusive in the qualifying eye(s)
- •Have pathologic myopia presenting - 6.0 diopters or more correction required OR an axial length of the >/= 26.5 mm
- •Be able and willing to avoid any medication that the investigator feels may interfere with the study
- •If female and of childbearing potential, agree to submit a sample for pregnancy testing and have a negative pregnancy test within 1 day prior to each treatment. Females are considered of childbearing potential unless they are surgically sterile or post-menopausal for 12 months. Females of childbearing potential must agree to an approved form of contraception for the duration of the study.
排除标准
- •Have contraindications, allergies or sensitivity to the use of the study medications
- •Have clinical signs or symptoms, in the opinion of the investigator, that may interfere with the study
- •Features of any condition other than pathologic myopia associated with CNV, such as age-related macular degeneration
- •Have a tear of the retinal pigmented epithelium
- •Have undergoing ocular therapy/surgery or major surgery in the last 3 months or have any surgeries planned during the study period
- •Have any significant illness or condition, ocular or systemic that could, in the opinion of the investigator, be expected to interfere with the study
- •Have angina (stable or severe, even if controlled with medications), 6 months S/P myocardial infarction ,congestive heart failure, history of or presence of any clinically significant supraventricular or ventricular arrhythmias or syncope episodes
- •Have ECG with QTc >450 msdec or other clinically significant abnormalities such as left bundle branch block, left ventricular hypertrophy, etc.
- •Have uncontrolled QTc prolongation
- •Take any drugs known to prolong the QTc interval however subject can remain eligible if a non-QTc substitute can be administered
- •Have uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mm Hg irrespective of medication)
- •Uncontrolled hypokalemia and/or hypomagnesemia
- •Have symptomatic peripheral vascular disease or cerebrovascular disease
- •Have psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol
- •Be receiving concurrent hormonal therapy with exception of Gonadotropin-releasing hormone agonists in subjects with hormone refractory prostate cancer, hormone replacement therapy, oral contraceptive, and megestrol acetate used for anorexia/cachexia
- •Be receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of Hickman line patency
- •Be a woman who is currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
- •Have participated in an investigational drug or device trial within 30 days of entering the study
研究组 & 干预措施
36 mg/m2 Combretastin A-4 Phosphate
Experimental
干预措施: Combretastatin A-4 Phosphate (Drug)
45 mg/m2 Combretastatin A-4 Phosphate
Experimental
干预措施: Combretastatin A-4 Phosphate (Drug)
27 mg/m2 Combretastatin A-4 Phosphate
Experimental
干预措施: Combretastatin A-4 Phosphate (Drug)
结局指标
主要结局
Visual acuity line change from baseline at 3-month following
时间窗: from baseline to 3 months
Visual acuity response category at 3-month follow-up
时间窗: from baseline to 3 months
次要结局
- Visual acuity line change from baseline at 1 month follow-up(from baseline to 1 month)
- Visual acuity response category at 1 month follow-up(from baseline to 1 month)
- Number of patients with treatment emergent adverse events(from first dose of study drug to 30 days after last dose of study drug)
研究者
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