Clinical trial NCT01423149: Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Official title: A Phase II, Dose Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating Subfoveal Choroidal Neovascularization in Subjects With Pathologic Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Neovascularization
Myopia, Degenerative
Keywords: subfoveal choroidal neovascularization
pathologic myopia
Lead sponsor: Mateon Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual acuity line change from baseline at 3-month following
timeFrame: from baseline to 3 months
measure: Visual acuity response category at 3-month follow-up
timeFrame: from baseline to 3 months
Secondary outcomes:
measure: Visual acuity line change from baseline at 1 month follow-up
timeFrame: from baseline to 1 month
measure: Visual acuity response category at 1 month follow-up
timeFrame: from baseline to 1 month
measure: Number of patients with treatment emergent adverse events
timeFrame: from first dose of study drug to 30 days after last dose of study drug
Other outcomes:
Locations:
Study officials:
References: