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

ISRCTN	ISRCTN85551991
DOI	https://doi.org/10.1186/ISRCTN85551991
Secondary identifying numbers	MMD-213

Submission date: 07/12/2006
Registration date: 19/12/2006
Last edited: 08/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr David Brown
Scientific

Vitreoretinal Consultants
6560 Fannin St., Ste. 750
Houston
77030
United States of America

Study information

Study design	A phase II, dose ranging, multi-centre study
Primary study design	Interventional
Secondary study design	Multi-centre
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	To evaluate the safety and efficacy of three dose groups (27, 36 and 45 mg/m^2) of Combretastatin A4 Phosphate for the treatment of subfoveal Choroidal NeoVascularization (CNV) in subjects with pathologic myopia.
Ethics approval(s)	Western Institutional Review Board, Local Institutional Review Boards, and the Food and Drugs Adminstration (FDA).
Health condition(s) or problem(s) studied	Pathologic myopia; mypoic macular degeneration
Intervention	Combretastatin A4 Phosphate (CA4P) versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Combretastatin A4 Phosphate
Primary outcome measure	Best corrected ETDRS visual function (visual acuity) as evaluated by a masked grader.
Secondary outcome measures	1. Fluorescein angiography as evaluated by a masked grader; 2. Optical Coherence Tomography (OCT) as evaluated by a masked grader.
Overall study start date	11/01/2004
Completion date	03/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	23
Key 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
Key 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
Date of first enrolment	11/01/2004
Date of final enrolment	03/01/2007

Locations

Countries of recruitment

Canada
Russian Federation
Taiwan
United States of America

Study participating centre

Vitreoretinal Consultants

Houston
77030
United States of America

Sponsor information

Oxigene (USA)
Industry

230 Third Avenue
Waltham
02451
United States of America

"ROR"	https://ror.org/00cj7p033

Funders

Funder type

Industry

Oxigene (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan