Condition category
Eye Diseases
Date applied
07/12/2006
Date assigned
19/12/2006
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.oxigene.com

Contact information

Type

Scientific

Primary contact

Dr David Brown

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Pathologic myopia; mypoic macular degeneration

Intervention

Combretastatin A4 Phosphate (CA4P) versus placebo

Intervention type

Drug

Phase

Phase II

Drug names

Combretastatin A4 Phosphate

Primary outcome measures

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 trial start date

11/01/2004

Overall trial end date

03/01/2007

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes