Skip to Content

Ophthalmology clinical trial hailed as one of the most important of the Decade

5 minute read

Ophthalmology research at Queen's University Belfast has a long-standing international reputation which has been built around high-quality basic science, patient studies and clinical trials. Queen’s researchers have developed internationally-recognised expertise in the genetics and treatment of age-related macular degeneration (AMD).

Their clinical trial known as IVAN (Inhibition of VEGF in Age-related choroidal Neovascularisation) has led to a rapid impact on policy, practice, and debate around the globe.

Research Challenge

COST-EFFECTIVE TREATMENT FOR AGE-RELATED MACULAR DEGENERATION (AMD)

AMD is a common eye condition that affects more than 600,000 people in the UK and tens of millions globally. Without treatment, the condition can quickly lead to blindness.

The predominant modern treatment for AMD, an injectable drug named ranibizumab, can typically limit the loss of vision over 5 years, with many patients maintaining vision sufficient to hold a driving licence. However, the very high cost of ranibizumab imposes a huge burden on healthcare services around the world.

Ophthalmology researchers from Queen’s were funded by the NIHR Health Technology Assessment (HTA) programme to work with colleagues in the universities of Bristol, Liverpool, Oxford and Southampton, and with the NIHR Biomedical Research Centre at Moorfields Hospital in London and Oxford University Hospitals NHS Trust to conduct a randomised trial of the clinical and cost-effectiveness of alternative treatments to inhibit vascular endothelial growth factor (VEGF) in age-related choroidal neovascularisation.

Our Approach

RANDOMISED DRUG TRIAL AND WITHIN-TRIAL ECONOMIC EVALUATION

IVAN recruited, randomised and treated 610 participants across 23 ophthalmic units in the NHS from March 2008 to October 2010, with the final primary outcome being collected in November 2012. The trial sought to answer two main treatment questions through a head-to-head comparison of bevacizumab versus the more expensive ranibizumab, and a second randomisation of patients to continuous or discontinuous treatment.

The results showed that the two drugs improve eyesight by a similar amount and that monthly treatment improves eyesight slightly more than intermittent treatment and appeared to be safer.

The results, coupled with the within-trial economic evaluation of the incremental cost and cost-effectiveness of discontinuous and continuous treatment from the cost perspective of the NHS and the health perspective of participants clearly showed that ranibizumab was not cost-effective compared with bevacizumab.

Two years of treatment with ranibizumab cost more than £18,500 compared with £3000 for bevacizumab. The health economic analysis showed that continuous ranibizumab would only be cost effective compared with continuous bevacizumab if the NHS were willing to pay £3,500,000 million per quality-adjusted life year.

‘The IVAN trial led to significant cost savings for the NHS as well as leading to new clinical guidelines from the National Institute for Health and Care Excellence. It also had international repercussions: the trial's finding were  the basis for new recommendations in a World Health Organisation report.’ 

- NIHR Impact Case Study

What impact did it make?

SIGNIFICANT COST SAVINGS FOR THE NHS

The IVAN Trial has led to widespread demand by healthcare providers in the UK and internationally to be able to use the cheaper drug,

A 2019 case study published by National Institute for Health Research (NIHR) stated that the trial is regarded as one of the most important of the last decade. “It provided clear evidence that Avastin (bevacizumab) is a cheaper, effective alternative to Lucentis ranibizumab) for the treatment of AMD. In the UK, if Avastin were used as the treatment of choice, the NHS would be able to save millions of pounds each year.

The study findings have had an international impact, acting as the basis for recommendations made in the World Health Organisation’s (WHO) 2017 report ‘The selection and use of essential medicines’, and informed National Institute for Health and Care Excellence (NICE) clinical guidelines on the treatment of nAMD, concluding that Avastin was as safe and effective as Lucentis.

In September 2018, the findings of the IVAN trial helped win a landmark court ruling between two drug companies and 12 Northern Clinical Commissioning Groups (CCGs) which focused on the CCG’s decision to offer the drug which is not currently licensed to treat AMD.

 

Our impact

Impact related to the UN Sustainable Development Goals

Learn more about Queen’s University’s commitment to nurturing a culture of sustainability and achieving the Sustainable Development Goals (SDGs) through research and education.

UN Goal 03 - Good Health and well-being

Key Facts

  • In 2020, Queen’s was ranked among the top 20 institutions in the world for research into macular degeneration.

  • Lead researcher, Professor Chakravarthy is among the top dozen global experts in macular degeneration.

  • America
  • United Kingdom
Sub-themes
Improving welfare for humans and animalsInterventions and services to improve health and reduce inequality