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A randomised controlled trial of alternative treatments to inhibit VEGF in age-related choroidal neovascularisation
ISRCTN ISRCTN92166560
DOI 10.1186/ISRCTN92166560
ClinicalTrials.gov identifier
EudraCT number
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 Treatment with VEGF inhibition can be ‘safely’ withdrawn at 3 months with monthly review to detect CNV reactivation, i.e. criteria for re-starting treatment can be pre-specified to prevent any difference in average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.

On 08/10/2012 the anticipated end date was changed from 31/12/2010 to 30/11/2012.
Lay summary Lay summary under review 3
Ethics approval 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 30/11/2012
Status of trial Completed
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 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22555112
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23870813
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25079928
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
  Email 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
  Email frances.burns@royalhospitals.n-i.nhs.uk
Date applied 19/04/2007
Last edited 04/08/2014
Date ISRCTN assigned 19/04/2007
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