Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
MMD-213
Study information
Scientific title
Acronym
Study hypothesis
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).
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
Patient information sheet
Condition
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
Overall study end date
03/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
23
Participant 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
Recruitment start date
11/01/2004
Recruitment end date
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
Organisation
Oxigene (USA)
Sponsor details
230 Third Avenue
Waltham
02451
United States of America
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Oxigene (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|