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    Ranibizumab provides solid safety, efficacy in real-world population

    Data at 1 and 2 years follow-up indicated expected relative preservation of visual acuity


    Most patients (17,500) from the 20,000 evaluated at baseline had neovascular AMD followed by DME in about 1,700 patients.

    Another strength was that the LUMINOUS Study included a wider age range of patients than is seen in pivotal trials, Dr. Mitchell noted.

    For neovascular AMD, there are many patients under age 65 and a large number 85 years and older. Among these patients, 42.2% had a pigment epithelial detachment, 6.2% polypoidal choroidal vasculopathy, and 3.8% retinal angiomatous proliferation.

    Many patients with DME were younger than 50 years. The age range among patients with branch and central vein occlusion was wide and similar to the general population, he said.

    Another characteristic of the LUMINOUS Study was the wider distribution of baseline visual acuities compared with pivotal trials, with many patients having somewhat poor vision at study enrollment and a sizable proportion with 20/40 or better visual acuity.

    Many patients with DME had poorer visual acuity with others having visual acuity up to 20/40 or better. Among those with branch vein occlusion, Dr. Mitchell noted a trend toward better visual acuity compared with those with central vein occlusion.

    “The baseline visual acuity was higher in patients who had undergone previous treatment with ranibizumab compared with patients who were treatment-naïve for all indications,” Dr. Mitchell said.

    Ranibizumab-treated AMD patients had better visual acuity by about 6 to 7 letters compared with treatment-naïve patients.

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