Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring subfoveal choroidal neovascularization, pathologic myopia Read More

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