EU-FRB

The EU-FRB program aims to identify optimal treatment strategies based on independent robust high quality real-world data taking into account both the chronic nature of the disease and frequent comorbidities associated with retinal diseases. We will track the incidence of local (ocular) and systemic adverse events, which clinical trials have been unable to measure. Intravitreal treatments for retinal disorders are the most significant evolution in ophthalmology in the last decade. For many conditions (including diabetic retinopathy (DR) and age-related macular degeneration (AMD)), the new treatments were shown to be highly effective, resulting in unprecedented improvements in vision and quality of life. Both DR and AMD have common characteristics: 1) They are frequent and incidence increases: in 2013, there were 56 million patients affected by diabetes in Europe. DR is one of the major comorbidities of diabetes. The number of patients affected by AMD in the EU is expected to rise by almost 25% until 2050. 2) Both require long term follow-up and treament: the rate of recurrence of macular disease, and subsequent vision loss, is significant if treatment is withheld. Regular and close follow-up are necessary to achieve best visual outcomes and maintain vision. Most patients with neovascular AMD need to be treated regularly for a lifetime. Similar findings were reported in patients with DR as 50% of the patients still receive treatment after 3 years. Both AMD and DR are chronic conditions requiring lifelong treatment. 3) Patients with AMD and DR have a higher risk for co-morbidities such as cardiovascular disease, myocardial infarction, renal failure and stroke. Particularly in DR, renal failure, peripheral neuropathy, cardial and neurovascular complications are frequent. Similarly, the link between stroke, high blood pressure and AMD is well established. 4) Patients affected by either DME or AMD do greatly benefit from intravitreal antiVEGF injections, as shown in pivotal clinical studies. There is a need to assess the impact of comorbidities on outcomes, as patients with comorbidities are often excluded from clinical trials: these studies were performed in controlled environments with highly selected groups of patients to achieve high internal validity. Few real world data, mostly industry driven, are available. Systemic anti-VEGF, used as chemotherapy, had been shown to increase the risk of stroke, myocardial infarction, renal failure and hyper-blood pressure, but the impact of intra-vitreal injection is still debated. High-quality real-world outcomes data for DR and neovascular AMD treatments are urgently needed. Randomized clinical trials are inadequate to assess effects in life-long chronic diseases. EU-FRB We have formed a collaborative group with the expertise required to lead an international registry: ophthalmologists, epidemiologists, biostatistics, health economists, diabetologists, cardiologists and IT specialists. We aim to collect real-world data on retinal vascular disease, and related comorbidities at a European level. The EU-FRB project will fill a gap in our knowledge about how new and emerging treatments for retinal disorders can be used alone or in combination to produce the best outcomes for patients. This information will benefit to patients, health care professionals, and society. It will be the largest and continuously expanding international registry for ocular outcomes. By demonstrating the benefit of proposing a multi-disciplinary personalized treatment strategy based on observational data and using ICHOM specified outcomes, the EU-FRB project may support the use of similar registries in health. This project will place Europe at the forefront of international research on real-world outcomes of treatment by forming the most consistent registry to improve eye health and life of millions of patients.