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LUMINOUS interim analysis shows high intercountry variability of baseline characteristics

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NICE, France — The second interim analysis at 3 years of the LUMINOUS study showed high diversity of baseline characteristics across distinct geographies in terms of patient age, interval from diagnosis to treatment, and prevalence of pigment epithelium detachment and polypoidal choroidal vasculopathy.

“The LUMINOUS study has now reached the target enrollment of 30,000 patients. The purpose of this analysis was to describe the baseline characteristics of 17,546 patients with neovascular AMD across multiple countries recruited prior to March 2014,” Paul Mitchell, MD, said at the Euretina meeting.

Paul Mitchell

Globally, mean age at baseline was 77 years, ranging from around 80 years in west European countries, Canada and Australia to less than 70 years in China.

“If we look at the proportion of patients over 85, it is more than 30% in the western group and between 3% and 10% in China, Japan and east Europe. This reflects the overall mean age of the population,” Mitchell said.

Baseline visual acuity had little variation in the top 10 reporting countries but showed greater variability when other countries were included.

Great variability was reported in the time interval from diagnosis to treatment, which is administered within a week in Canada, Poland, Germany, China, the U.K. and Australia and approximately 1 month in Russia and Slovakia. Argentina reported the longest time interval, on average 127 days. “Completely suboptimal,” Mitchell said. “It reflects inner problems in terms of accessing treatment.”

Prevalence of pigment epithelium detachment varied greatly. Polypoidal choroidal vasculopathy was very low in Europe, Canada and Australia, while Asian countries such as Korea and Japan reached 30% prevalence. Surprisingly, a lower rate of 10.6% was found in China.

“The wide range of characteristics across distinct geographies emphasizes the value of real-world evidence and the value of intercountry analysis in global studies. LUMINOUS is an invaluable source of information on countries underrepresented in clinical trials,” Mitchell said. – by Michela Cimberle

Disclosure: Mitchell reports he is a consultant to Novartis, Bayer, Abbott and Allergan.