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| [ Print-friendly version ] |
| A randomised controlled trial of alternative treatments to inhibit VEGF in age-related choroidal neovascularisation |
| ISRCTN | ISRCTN92166560 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised controlled trial of alternative treatments to inhibit VEGF in age-related choroidal neovascularisation |
| Scientific title | |
| Acronym | IVAN |
| Serial number at source | HTA 07/36/01; Sponsor ref: RGHT000449 |
| 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 Treatment with VEGF inhibition can be ‘safely’ withdrawn at 3 months with monthly review to detect CNV reactivation, i.e. criteria for re-starting treatment can be pre-specified to prevent any difference in average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. |
| Ethics approval | Approved by the Health and Personal Social Services 3 in Northern Ireland (ref: 07/NI R03/37) |
| Study design | Multi-centre, factorial, randomised controlled trial. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Age-related macular degeneration (AMD) |
| 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 |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| 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) |
| Trial website | |
| Publications | |
| Contact name | Prof Usha Chakravarthy |
| Address |
The Queen’s University of Belfast
Centre for Vision Sciences Institute of Clinical Science The Royal Hospitals Grosvenor Rd |
| City/town | Belfast |
| Zip/Postcode | BT12 6BA |
| Country | United Kingdom |
| Tel | +44 (0)2890 632527 |
| Fax | +44 (0)2890 330744 |
| u.chakravarthy@qub.ac.uk | |
| Sponsor | Royal Group of Hospitals Trust (UK) |
| Address |
Royal Research Office
First Floor Education Centre The Royal Group of Hospitals Trust Grosvenor Road |
| City/town | Belfast |
| Zip/Postcode | BT12 6BA |
| Country | United Kingdom |
| Tel | +44 (0)2890632224 |
| Fax | +44 (0)2890634812 |
| frances.burns@royalhospitals.n-i.nhs.uk | |
| Date applied | 19/04/2007 |
| Last edited | 25/01/2008 |
| Date ISRCTN assigned | 19/04/2007 |
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