Contact information
Type
Scientific
Primary contact
Prof Usha Chakravarthy
ORCID ID
Contact details
The Queens University of Belfast
Centre for Vision Sciences
Institute of Clinical Science
The Royal Hospitals
Grosvenor Rd
Belfast
BT12 6BA
United Kingdom
+44 (0)2890 632527
u.chakravarthy@qub.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/36/01; Sponsor ref: RGHT000449
Study information
Scientific title
Acronym
IVAN
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 Treatment with VEGF inhibition can be safely withdrawn at 3 months with monthly review to detect CNV reactivation, i.e. criteria for re-starting treatment can be pre-specified to prevent any difference in average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.
Ethics approval
Health and Personal Social Services 3 in Northern Ireland, ref: 07/NI R03/37
Study design
Multi-centre factorial randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Age-related macular degeneration (AMD)
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
bevacizumab, ranibizumub
Primary outcome measures
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 measures
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).
Overall trial start date
01/07/2007
Overall trial end date
30/11/2012
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
30/11/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Queens University of Belfast
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Royal Group of Hospitals Trust (UK)
Sponsor details
Royal Research Office
First Floor Education Centre
The Royal Group of Hospitals Trust
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44 (0)2890632224
frances.burns@royalhospitals.n-i.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
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
Publication citations
-
Results
, Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, Toth C, Redford M, Ferris FL, Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results., Ophthalmology, 2012, 119, 7, 1388-1398, doi: 10.1016/j.ophtha.2012.03.053.
-
Results
Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, Reeves BC, , Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial., Lancet, 2013, 382, 9900, 1258-1267, doi: 10.1016/S0140-6736(13)61501-9.
-
Results
Dakin HA, Wordsworth S, Rogers CA, Abangma G, Raftery J, Harding SP, Lotery AJ, Downes SM, Chakravarthy U, Reeves BC, , Cost-effectiveness of ranibizumab and bevacizumab for age-related macular degeneration: 2-year findings from the IVAN randomised trial., BMJ Open, 2014, 4, 7, e005094, doi: 10.1136/bmjopen-2014-005094.