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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

OXiGENE

ClinicalTrials.gov Identifier:

NCT01423149

First received: August 22, 2011

Last updated: October 28, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 22, 2011
Last Updated Date	October 28, 2011
Start Date ^ICMJE	March 2005
Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 24, 2011)	Visual acuity line change from baseline at 3-month following [ Time Frame: from baseline to 3 months ] [ Designated as safety issue: No ] Visual acuity response category at 3-month follow-up [ Time Frame: from baseline to 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01423149 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 24, 2011)	Visual acuity line change from baseline at 1 month follow-up [ Time Frame: from baseline to 1 month ] [ Designated as safety issue: No ] Visual acuity response category at 1 month follow-up [ Time Frame: from baseline to 1 month ] [ Designated as safety issue: No ] Number of patients with treatment emergent adverse events [ Time Frame: from first dose of study drug to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Choroidal Neovascularization Myopia, Degenerative
Intervention ^ICMJE	Drug: Combretastatin A-4 Phosphate 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. Other Names: CA4P fosbretabulin
Study Arm (s)	Experimental: 36 mg/m2 Combretastin A-4 Phosphate Intervention: Drug: Combretastatin A-4 Phosphate Experimental: 45 mg/m2 Combretastatin A-4 Phosphate Intervention: Drug: Combretastatin A-4 Phosphate Experimental: 27 mg/m2 Combretastatin A-4 Phosphate Intervention: Drug: Combretastatin A-4 Phosphate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	23
Completion Date	January 2007
Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01423149
Other Study ID Numbers ^ICMJE	MMD-213
Has Data Monitoring Committee	Yes
Responsible Party	OXiGENE
Study Sponsor ^ICMJE	OXiGENE
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	OXiGENE
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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