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

Phase 2

Completed

• Conditions: Choroidal Neovascularization; Myopia, Degenerative
• Interventions: Drug: Combretastatin A-4 Phosphate

• Registration Number: NCT01423149
• Lead Sponsor: Mateon Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-25
• Status Verified: 2011-10
• Disposition First Submitted: 2011-10-28
• Disposition First Submitted QC: 2011-10-28
• Last Update Submitted: 2011-10-28
• Disposition First Posted: 2011-11-01
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
36 mg/m2 Combretastin A-4 Phosphate	Combretastatin A-4 Phosphate	-
45 mg/m2 Combretastatin A-4 Phosphate	Combretastatin A-4 Phosphate	-
27 mg/m2 Combretastatin A-4 Phosphate	Combretastatin A-4 Phosphate	-

Primary Outcome Measures

Name	Time	Method
Visual acuity line change from baseline at 3-month following	from baseline to 3 months
Visual acuity response category at 3-month follow-up	from baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
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