A phase II, dose ranging, multi-centre study to evaluate the safety and efficacy of combretastatin A4 phosphate for treating subfoveal choroidal neovascularization in subjects with pathologic myopia

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN85551991
• Date of registration: 19/12/2006
• Prospective Registration: No
• Primary sponsor: Oxigene (USA)
• Public title: A phase II, dose ranging, multi-centre study to evaluate the safety and efficacy of combretastatin A4 phosphate for treating subfoveal choroidal neovascularization in subjects with pathologic myopia
• Date of first enrolment: 11/01/2004
• Target sample size: 23
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN85551991
• Study type: Interventional
• Study design: A phase II, dose ranging, multi-centre study (Treatment)

Countries of recruitment

Canada, Russian Federation, Taiwan, United States of America

Contacts

• Name: David Brown

Key inclusion & exclusion criteria

Inclusion criteria: 1. Provide written informed consent
2. Be able and willing to follow instructions
3. Age 18 to 50 years old (inclusive)
4. Have area of choroidal neovascularization within 50 µm or under the geometric center of the foveal avascular zone
5. Have greatest linear dimension of lesion 5,400 µm or less, with more than or equal to 50% 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 less than 50%) as confirmed by Doheny Image Reading Center
6. Have best corrected distance visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] chart) of 20/20 to 20/200 (LogMAR +0.0 to 1.0), inclusive in the qualifying eye(s)
7. Have pathologic myopia presenting ? 6.0 diopters or more correction required OR an axial length of the eye more than or equal to 26.5 mm
8. Be able and willing to avoid any medication that the Investigator feels may interfere with the study
9. 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: 1. Have contraindications, allergies or sensitivity to the use of the study medications
2. Have clinical signs or symptoms, in the opinion of the investigator, that may interfere with the study
3. Features of any condition other than pathologic myopia associated with Choroidal NeoVascularization (CNV), such as Age-related Macular Degeneration (AMD)
4. Have a tear of the retinal pigment epithelium
5. Have undergone ocular therapy/surgery or major surgery in the last three months or have any surgeries planned during the study period
6. Have any significant illness or condition, ocular or systemic that could, in the opinion of the investigator, be expected to interfere with the study
7. Have angina (stable or severe, even if controlled with medications), six months s/p myocardial infarction, Congestive Heart Failure (CHF), history of or presence of any clinical significant supraventricular or ventricular arrhythmias or syncope episodes
8. Have Electrocardiogram (ECG) with QTc more than 450 msec or other clinically significant abnormalities such as left bundle branch block, left ventricular hypertrophy, etc.
9. Have uncontrolled QTc prolongation
10. Take any drugs(s) known to prolong the QTc interval however subject can remain eligible if a non-QTc substitute can be administered
11. Have uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mmHg irrespective of medication)
12. Uncontrolled hypokalemia and/or hypomagnesemia
13. Have symptomatic peripheral vascular disease or cerebrovascular disease
14. Have psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol
15. Be receiving concurrent hormonal therapy with exception of GnRH agonists in subjects with hormone refractory prostate cancer, Hormone Replacement Therapy (HRT), oral contraceptive, and megestrol acetate used for anorexia/cachexia
16. Be receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of Hickman line patency
17. Be a woman who is currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
18. Have participated in an investigational drug or device trial within 30 days of entering the study

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pathologic myopia; mypoic macular degeneration
Eye Diseases
Myopia

Intervention(s)

Combretastatin A4 Phosphate (CA4P) versus placebo

Primary Outcome(s)

Best corrected ETDRS visual function (visual acuity) as evaluated by a masked grader.

Secondary Outcome(s)

1. Fluorescein angiography as evaluated by a masked grader;
2. Optical Coherence Tomography (OCT) as evaluated by a masked grader.

Secondary ID(s)

MMD-213

Source(s) of Monetary Support

Oxigene (USA)