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The IVAN Trial

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

Summary of the IVAN Trial

Wet or neovascular age-related macular degeneration (nAMD) is a condition which causes severe sight loss in older people. This condition is due to a pathological process in which new blood vessels grow into the central region of the retina of the eye, known as choroidal neovascularisation (CNV). These vessels are leaky and lead to the accumulation of fluid between and within the layers of the retina with serious adverse effects on central vision.

Lucentis® is an 'anti-VEGF' drug which is injected monthly into the eye which causes these blood vessels to stop leaking and to shrink. With treatment, eyesight improves in a quarter of affected people and, in the majority (90% or more), eyesight does not deteriorate over two years. These results represent a major improvement over previous treatments. Another anti-VEGF drug, Avastin® (from which Lucentis was derived), may be equally good and is considerably less expensive but its efficacy and safety have only been studied in case series.

The IVAN trial is a head-to-head comparison of the efficacy and safety of Avastin® and Lucentis®. The IVAN trial is also studying whether the number of treatments needed can be reduced by comparing monthly anti-VEGF treatment for 2 years with monthly anti-VEGF treatment for 3 months only, with careful monthly review and re-starting treatment if any signs of disease recur.

The study will randomise patients to various combinations of active treatment; all patients recruited to the trial will receive anti-VEGF treatment in or other combination. Eyesight will be assessed at each visit and information collected on quality of life and the costs and burden of illness, which will be compared between the different groups after 1 and 2 years follow-up.

Although Lucentis has so far shown the best result of all the licensed anti-VEGF treatments in terms of maintained and improved eyesight, we believe that there will be benefits to patients if we can undertake fewer treatments without compromising eyesight. Patient support organisations agree that the IVAN trial is important and that it has considerable potential to benefit future patients.