LUMINOUS study interim results show VA preserved with ranibizumab
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CHICAGO — One- and 2-year follow-up data indicate expected preservation of visual acuity with relatively few injections of ranibizumab in patients with neovascular age-related macular degeneration, a speaker here said.
Giving results from the second interim analysis of the LUMINOUS study, Paul Mitchell, MD, PhD, told colleagues at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting that patients in the study represented a more diverse demographic population than patients in other pivotal trials of Lucentis (ranibizumab, Genentech) and, therefore, are more representative of real-world patients.
Paul Mitchell
LUMINOUS is a 5-year observational, noninterventional, multicenter, global study intended to provide long-term safety and effectiveness data for ranibizumab for all its licensed indications —that is, for the treatment of neovascular AMD, visual impairment due to diabetic macular edema, visual impairment due to macular edema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization secondary to pathologic myopia.
The LUMINOUS study enrolled 20,000 patients at baseline, with 10,000 patients followed at 1 year and 2,000 patients followed at 2 years. Mitchell said 30,000 patients are expected to complete the enrollment by March 2015, and final analysis is expected in March 2016.
“LUMINOUS will provide an invaluable source of long-term real world data,” Mitchell said.
Disclosure: Mitchell is a consultant for and has received honoraria, accommodation and travel support from Abbott, Allergan, Bayer and Novartis.