ISRCTN85551991已完成不适用
A phase II, dose ranging, multi-centre study to evaluate the safety and efficacy of combretastatin A4 phosphate for treating subfoveal choroidal neovascularization in subjects with pathologic myopia
Oxigene (USA)0 个研究点目标入组 23 人开始时间: 2006年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provide written informed consent
- •2. Be able and willing to follow instructions
- •3. Age 18 to 50 years old (inclusive)
- •4. Have area of choroidal neovascularization within 50 µm or under the geometric center of the foveal avascular zone
- •5. Have greatest linear dimension of lesion 5,400 µm or less, with more than or equal to 50% 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 less than 50%) as confirmed by Doheny Image Reading Center
- •6. Have best corrected distance visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] chart) of 20/20 to 20/200 (LogMAR +0.0 to 1.0), inclusive in the qualifying eye(s)
- •7. Have pathologic myopia presenting ? 6.0 diopters or more correction required OR an axial length of the eye more than or equal to 26.5 mm
- •8. Be able and willing to avoid any medication that the Investigator feels may interfere with the study
- •9. 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
- •1. Have contraindications, allergies or sensitivity to the use of the study medications
- •2. Have clinical signs or symptoms, in the opinion of the investigator, that may interfere with the study
- •3. Features of any condition other than pathologic myopia associated with Choroidal NeoVascularization (CNV), such as Age-related Macular Degeneration (AMD)
- •4. Have a tear of the retinal pigment epithelium
- •5. Have undergone ocular therapy/surgery or major surgery in the last three months or have any surgeries planned during the study period
- •6. Have any significant illness or condition, ocular or systemic that could, in the opinion of the investigator, be expected to interfere with the study
- •7. Have angina (stable or severe, even if controlled with medications), six months s/p myocardial infarction, Congestive Heart Failure (CHF), history of or presence of any clinical significant supraventricular or ventricular arrhythmias or syncope episodes
- •8. Have Electrocardiogram (ECG) with QTc more than 450 msec or other clinically significant abnormalities such as left bundle branch block, left ventricular hypertrophy, etc.
- •9. Have uncontrolled QTc prolongation
- •10. Take any drugs(s) known to prolong the QTc interval however subject can remain eligible if a non-QTc substitute can be administered
- •11. Have uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mmHg irrespective of medication)
- •12. Uncontrolled hypokalemia and/or hypomagnesemia
- •13. Have symptomatic peripheral vascular disease or cerebrovascular disease
- •14. Have psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol
- •15. Be receiving concurrent hormonal therapy with exception of GnRH agonists in subjects with hormone refractory prostate cancer, Hormone Replacement Therapy (HRT), oral contraceptive, and megestrol acetate used for anorexia/cachexia
- •16. Be receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of Hickman line patency
- •17. Be a woman who is currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
- •18. Have participated in an investigational drug or device trial within 30 days of entering the study
研究者
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