|
Welcome
|
|
12 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| Greater Manchester Avastin® for choroidal Neovascularisation trial |
| ISRCTN | ISRCTN34221234 |
| ClinicalTrials.gov identifier | |
| Public title | Greater Manchester Avastin® for choroidal Neovascularisation trial |
| Scientific title | |
| Acronym | GMAN |
| Serial number at source | 1.2 |
| Study hypothesis |
Disease studied: Wet age-related macular degeneration (AMD). There are two forms of AMD sometimes referred to as "dry" and "wet" macular degeneration. The "wet" form accounts for about 10% of AMD but, because it is the more severe form, accounts for 90% of blind registrations due to AMD. The "wet" form of AMD is caused by choroidal neovascularisation (CNV) i.e. abnormal new blood vessels derived from the choroid growing into the macula (the central part of the retina that is used for detailed vision) and from hereon will be referred to as neovascular AMD. These new blood vessels leak and bleed and eventually a scar forms, this process results in the progressive loss of central vision. Furthermore, the condition frequently affects both eyes.
The purpose of the study is to demonstrate that a treatment regime over 12 and 24 months where intravitreal bevacizumab for treatment of neovascular age related macular degeneration is given monthly for three months and then on a prn ("when necessary") basis at three monthly intervals, the "PRN" treatment arm, is not inferior to a regime where bevacizumab is given monthly for three months and then every three months irrespective of clinical symptoms and signs, the "Routine" treatment arm, with respect to best-corrected visual acuity (BCVA). |
| Lay summary | |
| Ethics approval | Approved by the South West Research Ethics Committee (ref: 07/H0206/57) |
| Study design | Single-centre, randomised, controlled, single-masked trial. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Age-related macular degeneration |
| Participants - inclusion criteria |
1. Men or women of any ethnic background over the age of 50 years with AMD
2. Subfoveal choroidal neovascularisation or juxtafoveal choroidal neovascularisation where laser would ablate the centre of the foveal avascular zone (FAZ) 3. Predominantly-classic CNV or minimally classic or occult with no classic CNV lesion composition where there is evidence of recent disease progression (i.e. vision loss, lesion growth on fundus fluorescein angiogram [FFA], progression on optical coherence tomography [OCT] examination, new blood associated with lesion within the preceding three months) 4. The total area of CNV within the lesion (including classic and occult components) must be greater than 50% of the lesion area as defined by FFA 5. The BCVA letter score must be between logMAR 0.3–1.2 (approximately 6/12 to 6/96 Snellen equivalent) 6. Patients must have completed study consent forms and must be willing and able to comply with all of the study protocols |
| Participants - exclusion criteria |
1. Prior treatment to the CNV lesion
2. Lesion components including fibrosis, haemorrhage or serous pigment epithelial detachment representing greater than 50% of the lesion 3. Retinal pigment epithelial tear (rip) 4. Active intraocular inflammation within one month of screening for study 5. Active or suspected ocular or periocular infection 6. Uncontrolled glaucoma in study eye (intra-ocular pressure [IOP] of greater than 25 mmHg despite anti-glaucomatous medication) 7. History of ocular surgery or YAG (yttrium aluminium garnet) laser capsulotomy within two months of screening for study 8. History of allergy to fluorescein 9. Any systemic medication that may interfere with the safety of the patient or is known to be toxic to the retina 10. Uncontrolled hypertension 11. Within one month of major surgery 12. History of myocardial infarction, stroke or gastrointestinal perforation 13. Episode of angina or transient ischaemic attack within 6 months of screening 14. Pregnant and or lactating women 15. Women of child-bearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use effective contraception during the study and for 6 months after Bevacizumab treatment has stopped 16. Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms |
| Anticipated start date | 03/02/2008 |
| Anticipated end date | 30/04/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 330 |
| Interventions |
Initially, all participants will be treated with 1.25 mg intravitreal bevacizumab (Avastin®) on Day 1 and 1 and 2 months. After this period, the "Routine" treatment arm will receive 1.25 mg bevacizumab at 5, 8, 11, 14,17, 20 and 23 months, and the "PRN" arm will receive the same treatment only when clinical signs of deterioration of vision or progression of the CNV lesion are observed.
All patients will be seen by a clinician at Day 1 and 1, 2, 5, 8, 11, 14, 17, 20 and 23 months. There will be a final assessment visit at month 24. If patients suffer a marked drop in vision of more than 5 letters from the best corrected visual acuity recorded three months earlier there will be an additional interim treatment visit 6 weeks later aimed at stabilising the vision. |
| Primary outcome measure(s) |
1. Visual acuity outcomes. Duration of follow-up: 24 months
2. Safety: adverse event reports and vital signs. Duration of follow-up: 24 months |
| Secondary outcome measure(s) |
1. Investigation of equivalence between two arms using additional measures of visual function including contrast sensitivity (CS), reading speed (RS), and radial deformation acuity (RDA)
2. To evaluate the efficacy of the two bevacizumab treatment regimes by changes in visual function (BCVA, CS, RS, and RDA) from baseline over 11 and 24 months 3. To determine the mean number of treatments required in the PRN treatment arm after month 2 and for the patients that require further treatments after month 2 the mean time interval until this retreatment is required 4. To investigate the correlation between BCVA and additional measures of visual function (CS, RS, and RDA), and assess the variability of these measures over time, to establish the clinical usefulness of these measures in determining change over time in patients with CNV 5. To evaluate the efficacy of the two bevacizumab treatment regimes by measuring changes from baseline of OCT and FFA parameters over 11 and 24 months 6. To explore the temporal changes in BCVA at months 1, 2 and 3 to evaluate the onset of treatment effect 7. To undertake pharmacogenetic studies to determine whether any variations in treatment response can be attributed to identifiable genetic variations |
| Sources of funding | Greater Manchester NHS Primary Care Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Paul Bishop |
| Address |
Manchester Royal Eye Hospital
Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9WH |
| Country | United Kingdom |
| Tel | +44 (0)1612755755 |
| Fax | +44 (0)1612751505 |
| Paul.Bishop@manchester.ac.uk | |
| Sponsor | Central Manchester & Manchester Children's Hospital NHS Trust (UK) |
| Address |
R & D, 1st Floor
Postgraduate Centre Manchester Royal Infirmary Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9WL |
| Country | United Kingdom |
| Tel | +44 (0)1612764182 |
| Fax | +44 (0)1612765766 |
| Keith.Chantler@cmmc.nhs.uk | |
| Sponsor website: | http://www.cmmc.nhs.uk |
| Date applied | 25/02/2008 |
| Last edited | 31/07/2008 |
| Date ISRCTN assigned | 31/07/2008 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|