PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF COMBINATION RANIBIZUMAB AND KETOROLAC FOR WET AGE-RELATED MACULAR DEGENERATION

Purpose:to evaluate whether ketorolac eyedrops and ranibizumab intravitreal injections would provide additional efficacy over ranibizumab alone in wet age-related macular degeneration.
Methods: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.
Results: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.
Conclusions: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.