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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mateon Therapeutics
• Treatments: Combretastatin; Fosbretabulin

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