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A randomised controlled trial of alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularisation

Dates: 2007-to date
Funding: NIHR Health Technology Assessment programme (HTA)
Collaborators: Belfast University and Bristol University
Information: Sarah Wordsworth, Helen Dakin

Macular degeneration comprises a group of diseases characterised by the gradual breakdown of the macula (the central portion of the eye). Since most cases of macular degeneration occur in older people, the condition is commonly referred to as age-related macular degeneration (AMD). AMD is the most common cause of blindness in the UK and is thought to affect one in ten people over 50 years of age. There are two types of AMD – a wet form and a dry form. Although it occurs less commonly than dry AMD, wet AMD is more severe and leads to more rapid degeneration of vision. Wet AMD frequently involves choroidal neovascularisation (CNV), in which abnormal blood vessels stemming from the choroid (the blood vessel-rich tissue layer just beneath the retina) grow up through the retinal layers. Patients’ symptoms may be very mild (such as a blurry or distorted area of vision), or more severe (such as a central blind spot).

The IVAN trial evaluated two alternative treatments that inhibit vascular endothelial growth factor (VEGF): Avastin (bevacizumab) and Lucentis (ranibizumab). The trial used a factorial design to compare two dosing regimens for each drug:
• continuous monthly treatment for two years
• discontinuous therapy, whereby patients received three monthly injections and were then monitored monthly for the remainder of the two-year study period, with treatment being repeated if there were any signs that the condition has worsened, in order to prevent loss of visual acuity.

The main aim of the economic evaluation component of the study was to assess:
•    The relative costs and incremental cost-effectiveness of Avastin versus Lucentis and
•    The relative costs and incremental cost-effectiveness of continuous versus discontinuous treatment.
Data on both quality of life and health service costs were collected prospectively as part of the trial. The cost data collected included the cost of treatment, monitoring, adverse events or complications and contacts with medical professionals.

Recruitment was completed in October 2010 and follow-up, data collection and analysis are now complete. For further information, see: http://cteu.bris.ac.uk/trials/ivan/.

IVAN has been used in methodological work comparing methods for costing consultations, analysing factorial trials and estimating QALY reductions from adverse events. Data are also being used to develop models predicting EQ-5D utilities from vision measures and disease-specific instruments.

Publications:

Dakin, HA, Wordsworth, S, Rogers, CA, Abangma, G, Raftery, J, Harding, SP, Lotery, AJ, Downes, SM, Chakravarthy, U, and Reeves, BC (2014). Cost-effectiveness of ranibizumab and bevacizumab for age-related macular degeneration: 2-year findings from the IVAN randomised trial. BMJ Open, 4(7):e005094.

Chakravarthy U1, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, Reeves BC; IVAN study investigators (2013). Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet. 382(9900):1258-67

Chakravarthy, U, Harding, SP, Rogers, CA, Downes, SM, Lotery, AJ, Wordsworth, S, and Reeves, BC (2012). Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology, 119(7):1399-411.

Conference Presentations:

Dakin H, Wordsworth S, Gray A, Rogers C, Abangma G, Reeves R. 'Why consider interactions in trial-based economic evaluation? A case study of a factorial trial' Presented at Health Economists' Study Group meeting June 2012, Oxford. 2012.

Dakin, H, Wordsworth, S, Abangma, G, & on behalf of the IVAN Study Investigators. (2013). What is the value of collecting detailed costing data in clinical trials? Presented at the MRC Network of Hubs for Trials Methodology Research (HTMR) Costing Workshop, Oxford UK, October 2013.

Dakin, H, Wordsworth, S, Rogers, C, Raftery, J, Reeves, B, & on behalf of the IVAN Study Investigators. (2013). Calculating quality of life and QALY reductions from clinical events: impact of measuring utility after adverse events. Presented at the 9th World Congress of the International Health Economics Association in Sydney, Australia in July 2013.

Rogers C, Dakin H, Wordsworth S, Abangma G, Raftery J, Harding H, Chakravarthy U, Lotery A, Downes S and Reeves B, on behalf of the IVAN Study Investigators. Cost-effectiveness of ranibizumab and bevacizumab for neovascular age-related macular degeneration: One year IVAN results. Presented at the Association for Research in Vision and Ophthalmology (ARVO) conference, May 2013.

Dakin, H, Wordsworth, S, Gray A, Rogers C, Abangma G, Reeves R. 'Why consider interactions in trial-based economic evaluation? A case study of a factorial trial' Presented at Health Economists' Study Group meeting June 2012, Oxford. 2012.

The IVAN Study Investigators, Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC. Ranibizumab versus Bevacizumab to Treat Neovascular Age-related Macular Degeneration: One-Year Findings from the IVAN Randomized Trial. Ophthalmology 2012;119(7):1399-1411.

IVAN study investigators. Alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularization (IVAN): 1 Year Results. Presented at the ARVO conference, May 2012.

Abangma G, Dakin H, Wordsworth S. Micro-costing, gross-costing or HRGs: Does the choice of cost approach matter in clinical trials? Podium presentation at the International Health Economics Association (iHEA) 8th World Congress, Toronto, Canada, 10th-13th July 2011 2011.

Dakin H, Abangma G and Wordsworth S. What is the value of collecting detailed costing data in clinical trials? Podium presentation at the Clinical Trials Methodology Conference, Bristol, UK, October 2011. Abstract published as Trials 2011 12(Suppl 1):A42. http://www.trialsjournal.com/content/pdf/1745-6215-12-S1-A42.pdf.