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| A randomised controlled trial of alternative treatments to inhibit VEGF in age-related choroidal neovascularisation |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN92166560 |
| Date ISRCTN assigned | 19/04/2007 |
| Local reference number(s) | HTA 07/36/01; Sponsor ref: RGHT000449 |
| Public title | A randomised controlled trial of alternative treatments to inhibit VEGF in age-related choroidal neovascularisation |
| Scientific title | |
| Acronym | IVAN |
| Disease/condition/study domain | Age-related macular degeneration (AMD) |
| Study hypothesis | 1. Avastin® (bevacizumab) is not inferior to Lucentis® (ranibizumub) with respect to the benefits of vascular endothelial growth factor (VEGF) inhibition in maintaining/improving visual acuity in eyes with chorodial neovascularisation (CNV). 2. Treatment with VEGF inhibition can be ¿safely¿ withdrawn at 3 months with monthly review to detect CNV reactivation, i.e. criteria for re-starting treatment can be pre-specified to prevent any difference in average visual acuity compared with continuing monthly treatment. |
| Design/methodology | Multi-centre, factorial, randomised controlled trial. |
| Research ethics review | Approved by the Health and Personal Social Services 3 in Northern Ireland (ref: 07/NI R03/37) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Adults age ≥50 of either sex 2. Newly referred for the treatment of CNV caused by Age-related Macular Degeneration (AMD) in the first or second eye 3. Corrected 1 metre logarithmic minimal angle resolution visual acuity (VAlogMAR) ≥25 letters read on a standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart 4. CNV involving the centre of the fovea If a fellow eye develops CNV from AMD, it will be treated with the optimal locally available treatment. |
| Participants - exclusion criteria | 1. Corrected 1 metre VAlogMAR <25 letters 2. Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion 3. Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy 4. Previous treatment with PhotoDynamic Therapy (PDT) or a VEGF inhibitor in the eye being considered for inclusion |
| Patient information material | |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Ongoing |
| Target number of participants | 600 |
| Interventions | Participants, clinical staff and researchers will be masked to allocation of VEGF inhibition drug but not to stopping/continuing treatment at three months. Factor 1: Intravitreal injection using either Avastin® or Lucentis® (VEGF inhibition drugs). Factor 2: Intravitreal injection of VEGF inhibition drug, either monthly for 2 years or monthly for 3 months with subsequent monthly review to detect CNV reactivation. |
| Primary outcome measure(s) | The primary outcome is corrected 1 metre VAlogMAR, measured as the number of letters read on a standard ETDRS chart. The primary end point will be VAlogMAR after two years of follow-up. |
| Secondary outcome measure(s) | Secondary outcomes will be analysed after one and two years of follow-up, unless otherwise stated. 1. Frequencies of adverse effects of treatment 2. Generic and vision-specific health-related quality of life (HRQoL) 3. Treatment satisfaction 4. Cumulative resource use/cost, and cost-effectiveness 5. Clinical measures of vision 6. CNV morphology (from masked grading of fundus fluorescein angiograms [FFA] and optical coherence tomography scans [OCTs]). 7. Distance VAlogMAR after all patients have been followed for 1 year after starting treatment. 8. Survival free from treatment failure (i.e. satisfying one or more of the criteria for re-treatment). |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Royal Group of Hospitals Trust (UK) |
| Sponsor details | Royal Research Office First Floor Education Centre The Royal Group of Hospitals Trust Grosvenor Road Belfast United Kingdom BT12 6BA |
| Sponsor telephone | +44 (0)2890632224 |
| Sponsor fax | +44 (0)2890634812 |
| Sponsor email | frances.burns@royalhospitals.n-i.nhs.uk |
| Contact name | Prof Usha Chakravarthy |
| Contact details | The Queen¿s University of Belfast Centre for Vision Sciences Institute of Clinical Science The Royal Hospitals Grosvenor Rd Belfast United Kingdom BT12 6BA |
| Contact telephone | +44 (0)2890 632527 |
| Contact fax | +44 (0)2890 330744 |
| Contact email | u.chakravarthy@qub.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN92166560 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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