REALITY CHECK

Closer adherence to published protocols concerning anti- VEGF use, and more aggressive treatment of patients with neovascular AMD could help to improve visual outcomes in these patients, according to Frank Holz MD. Presenting data from the AURA study, an international retrospective analysis of the real-world utilisation of anti-VEGF therapy in neovascular age-related macular degeneration, Dr Holz told delegates attending the 13th EURETINA Congress in Hamburg, that physicians need to consider ways to improve adherence to the published guidelines and recommendations in order to improve the functional benefit of breakthrough anti-VEGF therapy.

“We found overall that the real life utilisation of anti-VEGF therapy was associated with a poorer outcome than might have been expected based on the results from the pivotal prospective randomised clinical trials of ranibizumab. What is clear is that factors such as the monthly visits and the number of injections seem to play a very important role in maximising outcomes, as countries with a higher number of visits and higher number of injections showed better performance in terms of visual outcomes of the patients,” he said. The objectives of the AURA study were to collect “real life” data on clinical management patterns and resources utilisation in patients with exudative AMD being treated with anti-VEGF therapy in routine clinical practice, said Dr Holz.

The clinical endpoints of the study were to evaluate changes in visual acuity and resource utilisation in terms of overall visits, visual acuity and OCT tests and treatment use following anti-VEGF treatment with up to 2.5 years follow-up. A total of 2,671 patients were enrolled in the study, with 2,227 included in the final effectiveness analysis set. Data was collated from centres in Canada, France, Germany, Ireland, Italy, Netherlands, UK and Venezuela.

Two years of treatment with ranibizumab resulted in no observed change in visual acuity final score in patients with neovascular AMD in this study, said Dr Holz, and the overall number of visits, monitoring visits and number of injections were lower in the second year than in the first year. Overall, 9.8 visual acuity tests were performed over the study duration. Patients received a mean of five injections in the first year and two injections in the second year.

Patients in the UK fared the best, while results varied in the other countries. There are a number of possible explanations for the disparity in outcomes obtained in participating countries, said Dr Holz, some of which might be health-system related or physician- or patient-related.

“When we look at reasons why the United Kingdom performed better than the other countries, we see that the average number of patient visits there was 18.4 over two years, compared to Germany, for example, where it was 10.8. And the number of injections in the United Kingdom was nine while in the other countries it was almost half that. So it seems reasonable to conclude that how closely these patients are monitored, examined and re-injected if necessary seems to be a driving factor in their outcomes,” he said. Dr Holz added that poorer than expected visual outcomes were due to less than monthly monitoring and low numbers of treatments per year.

“Although these results are certainly much better than untreated evolution of neovascular AMD, consideration should be given to closer adherence to published protocols and/or potential barriers to optimal PRN treatment,” he concluded.