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Andrea Russo, Ciro Costagliola, Luisa Delcassi, Mario Romano, Francesco Semeraro; PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF COMBINATION RANIBIZUMAB AND KETOROLAC FOR WET AGE-RELATED MACULAR DEGENERATION. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4175.
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to evaluate whether ketorolac eyedrops and ranibizumab intravitreal injections would provide additional efficacy over ranibizumab alone in wet age-related macular degeneration.
this was a single-site, prospective, open-label, interventional, pilot study of patients with new wet age-related macular degeneration. Sixty eyes were enrolled consecutively and were randomized in a ratio of 1:1 to combination therapy with intravitreal ranibizumab and topical ketorolac, and ranibizumab alone. Ranibizumab was injected monthly for 3 months, then as needed in accordance with standard of care. Patients treated with ketorolac self-administered 1 drop twice a day for 6 months. Patients were followed monthly for 6 months.
no statistically significant differences were identified in best-corrected visual acuity or the number of injections required. However, the mean 6-month change in central macular thickness in the combination group was 146.53 µm while in the ranibizumab group alone the change was 106.88 µm (P = 0.03). The proportion of eyes experiencing a decrease in CMT of 50 µm or more was also significantly higher in those receiving combination therapy (P = 0.04). There were no safety concerns with the combination therapy.
this pilot study is the first to prospectively identify an additional effect of ketorolac eyedrops and ranibizumab intravitreal injections compared to treatment with ranibizumab alone in wet age-related macular degeneration.
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