Choroidal Neovascularization, Myopia, Degenerative
Conditions
Keywords
subfoveal choroidal neovascularization, pathologic myopia
Brief 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.
Interventions
Combretastatin A-4 Phosphate is administered on Day 0 and Day 7 (+/- 2 days). If the treating ophthalmologist notes any leakage from CNV in the study eye on a fluorescein angiography during the study or an increase in subretinal fluid on an optical coherence tomography measurement, retreatment with Combretastatin A-4 Phosphate is recommended with up to 3 additional treatments. The retreatment visit(s) could occur during a scheduled visit or at an additional visit 1 week after a regular study visit. A post-retreatment follow-up visit is necessary.
Sponsors
Mateon Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity response category at 3-month follow-up | from baseline to 3 months |
| Visual acuity line change from baseline at 3-month following | from baseline to 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity line change from baseline at 1 month follow-up | from baseline to 1 month |
| Visual acuity response category at 1 month follow-up | from baseline to 1 month |
| Number of patients with treatment emergent adverse events | from first dose of study drug to 30 days after last dose of study drug |
Outcome results
None listed