Twelve-month results of treatment with intravitreal ranibizumab, intravitreal ranibizumab plus ketorolac eye drops, and intravitreal ranibizumab plus low-fluence photodynamic therapy for exudative age-related macular degeneration

Purpose To compare the effectiveness of treatment with intravitreal ranibizumab (IVR), IVR plus ketorolac eye drops, and IVR plus low-fluence photodynamic therapy (PDT) for choroidal neovascularization (CNV). Methods This was a multicenter, prospective, pilot study of eyes with new-onset CNV. Seventy-five eyes were enrolled consecutively and randomized to one of 3 groups at a ratio of 1:1:1. Group 1 (n = 25) received IVR; Group 2 (n = 25) received IVR along with topical ketorolac eye drops 3 times a day; while Group 3 (n = 25) received 1 session of low-fluence PDT followed by IVR. In all groups, ranibizumab 0.5 mg was injected monthly for 3 months, and then as needed in accordance with the standard of care. All patients were followed up for 12 months. Results At 12 months, all groups showed significant improvements in best-corrected visual acuity (BCVA; p < 0.001). Group 2 showed a greater mean 12-month BCVA improvement than both groups 1 and 3 (p = 0.049 and p = 0.039, respectively). The mean 12-month change in central macular thickness (CMT) was -131 µm (-29.4%; p < 0.001) in Group 1, -138 µm (-33.4%; p < 0.001) in Group 2, and -129 µm (-29.5%; p < 0.001) in Group 3. Group 2 showed a greater mean CMT reduction than both Groups 1 and 3 (p = 0.002 and p = 0.014, respectively), while anatomical improvements were similar between Groups 1 and 3. None of the 3 groups showed any adverse effects. Conclusions This is the first study to report better BCVA outcomes over a 12-month period with a combination of 0.45% ketorolac eye drops 3 times a day and IVR in patients with CNV, further indicating that topical ketorolac supplements the CMT-reducing activity of IVR in CNV. A combination therapy of PDT plus ranibizumab injections did not yield anatomical or functional improvements; however, fewer ranibizumab injections were required. Larger trials are needed to confirm the findings of this pilot study.