VIENNA — One-year findings of the LUMINOUS study, the first global, large-scale observational study on ranibizumab in routine clinical practice, showed good disease control, with maintained or increased vision and a complication rate comparable to that of clinical trial settings.
The study is gradually recruiting a total of 30,000 patients with age-related macular degeneration, diabetic macular edema and retinal vein occlusion over a period of 3 years, with a possible extension to 4 years and an additional 10,000 patients. The United Kingdom, Canada, Australia, China and Russia are involved, and other countries are expected to join the project. Treatment-naïve and previously treated eyes are included and analyzed separately.
“A mean gain of 4.1 letters was achieved at 1 year with a mean number of 5.2 injections and seven visits by the treatment-naïve group,” Paul Mitchell, MD, said in an interview with Ocular Surgery News here at the Advanced Retina Therapy meeting. “Although recommendations for monthly monitoring are obviously disregarded, and the number of injections is fairly low, results seem quite good. We should also take into account that amongst the real-world population, there may be quite a few nonresponders.”
Eyes previously treated reported a mean loss of one letter, “almost no change,” Mitchell said, “with a similar number of injections. Vision is maintained remarkably well on average.”
Adverse events were within the type and average number found in clinical trials, showing a good safety profile of the treatment.
Mitchell said that these overall positive results are related to countries where Lucentis (ranibizumab, Novartis/Genentech) is available and there are no major impediments to therapy. A different picture might appear with the inclusion of countries where treatment availability and the delivery of services are more problematic.
Disclosure: Mitchell is a consultant to Novartis, Bayer, Pfizer, Allergan and Solvey.