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

Mateon Therapeutics

Status and phase

Completed

Phase 2

Conditions

Myopia, Degenerative

Choroidal Neovascularization

Treatments

Drug: Combretastatin A-4 Phosphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01423149

MMD-213

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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