Project overview
Central serous chorio-retinopathy (CSCR) is a poorly understood eye disease. It affects the eye tissue which senses light (the retina). In CSCR, fluid spontaneously gathers under the retina. This can lead to permanent vision loss in about 1/3 of cases. Some cases spontaneously resolve but some persist for years, recur or affect the second eye. Each year there are 10 new cases per 100,000 men and 2 cases per 100,000 women in the population. The cause is unknown although it can occur in families and some genetic changes have been found. There are no proven treatments. Recently our research team performed a clinical trial of a drug called Eplerenone in patients with CSCR to find out whether it is better than placebo treatment. This clinical trial was called the VICI Trial. We showed that eplerenone treatment had no effect in treating CSCR. This was an important result as it was previously one of the commonest treatments used to treat CSCR worldwide. Accordingly, our research, funded by the National Institute for Health Research, was published in a leading medical journal called The Lancet. Our research has changed clinical practice worldwide. However, doctors still do not know the best treatment for CSCR due to a lack of robust evidence. Another common treatment used for CSCR is photodynamic therapy (PDT). This is a laser therapy to the eye. However, the evidence for the effectiveness and safety of PDT treatment is limited. Nevertheless this is an existing standard therapy for CSCR in many NHS hospitals. We therefore now propose a new clinical trial called PAINT. PAINT will robustly test the effectiveness of photodynamic therapy (PDT) versus placebo. This will, for the first time confirm whether PDT laser is a safe and effective treatment for CSCR within a clinical trial setting. The PAINT Trial will look for biomarkers that might predict response to treatment in certain patients. This will include any changes we observe in the light sensing structure at the back of the eye called the retina and in any genetic risk factors. Our goal is to produce a more personalised treatment for CSCR patients. The PAINT Trial will be performed in 13 different NHS hospitals around the UK. The aim is to recruit 140 patients, who will either be treated with PDT laser or placebo for up to twelve months. The most important comparison between the two groups of patients is how much their vision improves with PDT compared to placebo. We will also look at changes in the structure of the retina after 12 months and the safety profile of PDT. The PAINT study team includes NHS patients as well as retinal specialists, clinical trialists, statisticians, molecular biologists. A Patient and Public Involvement (PPI) group will be will be asked about the set-up and running on the study, including whether materials produced for the study are suitable. The PPI group will also advise on the dissemination of results. This ensures that patients and their safety, remain at the centre of this research in to CSCR treatment options.
