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Global observational study on ranibizumab in real-life clinical practice enrolling worldwide
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The LUMINOUS study, the first global, large-scale observational study on ranibizumab in routine clinical practice, is successfully enrolling subjects worldwide.
According to Paul Mitchell, MD, steering committee member, the study will provide evidence of the long-term safety, effectiveness, treatment patterns and quality of life of patients treated with Lucentis (ranibizumab, Novartis/Genentech) in the real-life scenario of clinical practice worldwide.
Five hundred sites in 36 countries are in the process of recruiting 40,000 patients who will be followed for 6 years. Currently, 12,500 patients have been included.
“Following this large cohort of patients over the next 6 years is going to give us some very important insights,” Mitchell said.
Ranibizumab is used within the study for all approved indications, including neovascular age-related macular degeneration, retinal vein occlusion and diabetic macular edema. AMD patients represent the largest group and are divided in the study into two subgroups of naïve patients and patients who had previous AMD treatment.
“Baseline characteristics of the first cohort are consistent with those of AMD patients in routine clinical practice. Mean age is 79 years, which is the typical average age of neovascular AMD patients in all trials, but the proportion of the over-85 years is much greater than in other trials, which is going to provide a better look at people who might have additional risk factors,” Mitchell said.
Mean visual acuity was reported to be slightly greater in the non-naïve group than in the naïve group and slightly better than in the ANCHOR and MARINA studies, but not quite as good as in the CATT and IVAN studies. Type and size of lesions were similar between groups.
“Ocular comorbidities were twice as frequent in the non-naïve treatment group. Also, the number of previous medical and surgical procedures was significantly greater and intestinal disorders more frequent. Non-ocular comorbidities such as stroke, history of coronary disease and diabetes were also seen more frequently in the same group,” Mitchell said.
Disclosure: Mitchell is a consultant to Novartis, Bayer, Pfizer, Allergan and Solvey.