safety and efficacy study of combretastatin a4 phosphate to treat patients with choroidal neovascularization secondary to pathologic myopia

Conditions: Choroidal Neovascularization; Myopia, Degenerative

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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

Keywords: subfoveal choroidal neovascularization pathologic myopia