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Robert L. Avery, Dante Pieramici, Ma'an Nasir, Alessandro Castellarin, Robert See, Stephen Couvillion, Melvin Rabena, Jessica Basefsky; Ranibizumab for Macular Edema Secondary to Perfused Central Retinal Vein Occlusion- Three Year Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3967.
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To report long-term visual acuity and anatomic outcomes of patients treated with ranibizumab for macular edema associated with perfused central retinal vein occlusion.
Prospective, randomized clinical trial with monthly follow-up for 3 years. Patients were randomly assigned to receive intravitreal injections of either 0.3 or 0.5 mg dose of ranibizumab (N=20). After 3 monthly injections, Group 1 (N=10) received quarterly PRN injections and Group 2 (N=10) received monthly PRN in year one of the study. Beginning in the second year, all subjects (N=20) were switched to monthly PRN ranibizumab injections at the physician’s discretion for recurrent or persistent macular edema.
Twenty patients with an average age of 68.8 years were initially enrolled. Of the twenty patients, 19 were included in this combined group analysis. One patient withdrew from the study after 12 months due to relocation. After 1, 2 and 3 years of follow-up, mean BCVA from baseline improved by 1.0±24.8, 7.2±21.5, and 6.8±23.6 ETDRS letters; mean retinal thickness decreased by 187.8±249.75 um, 292.7±241.2 um, and 341.6±223.4 um. Mean number of injections during year 1, 2 and 3 of the study was 6.89±2.51, 3.42±3.86, and 3.05±3.20 respectively. Fourteen of the 19 patients required additional ranibizumab injections for recurrent macular edema during years 2 and 3 of this study. Twelve of 19 patients required injections in year 3. Mean number of injections for these subjects during years 2 and 3 was 8.78 (median=9, range = 1-21). Mean change in visual acuity for this subgroup (N=14) was an improvement of 1.07 (median= 3, range = -42 to +32) ETDRS letters at year 3 compared to baseline. Five patients did not require additional treatment and these subjects received an average of 4.4 injections in the first year with the last injection given at average of 5.8 months (range 3-10 months) from baseline. The average change in visual acuity for this subgroup was 22.8 (median=19.1, range= 4-46) ETDRS letters at year 3 compared to baseline. No subjects developed to iris neovascularization or experienced adverse events related to ranibizumab.
Ranibizumab was well tolerated throughout the entire study. Nearly two-thirds of the patients required additional ranibizumab treatment when followed for three years. While many CRVOs will resolve, most patients with macular edema due to CRVO will require continued follow-up and treatment for years.
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