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J. Basefsky, D. Peiramici, R. Avery, M. Nasir, A. Castellarin, M. Rabena, S. Risard; Ranibizumab for Macular Edema Associated With Central Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5399.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the biologic effect, visual acuity changes, and safety of intravitreal (IVT) ranibizumab in the treatment of macular edema (ME) associated with perfused central retinal vein occlusions (CRVO).
Patients with macular edema associated with perfused CRVO were enrolled in this ongoing prospective, open-label study, and were administered three monthly IVT ranibizumab (randomized 1:1 to 0.3mg or 0.5mg) injections and then were evaluated for PRN retreatment with additional ranibizumab over the ensuing 33 months if ME was present as determined by OCT. Patients in Cohort I (n=10) were evaluated quarterly for the first year, Cohort II patients (n=10) were evaluated monthly. All patients were evaluated and treated PRN monthly in the second and third years of the study. Standardized ETDRS vision and changes in OCT central retinal thickness (CRT) were evaluated over time. Fundus photographs and fluorescein angiograms were reviewed and the incidence and severity of adverse events (AEs) were documented.
The mean duration of CRVO prior to treatment was 20.7 / 13.4 weeks (range, 6-52 / 4-26 wks) (Cohort I / Cohort II). At baseline, best-corrected visual acuity (BCVA) was 56.6 / 46.22 ETDRS letters and CRT was 616.2 / 604.8 µm. At months 3, 6, and 12, BCVA improved by a mean of 11.6±11.0 / 4.5±4.5 letters, 3±7.5 / 6.8±13.5 letters, and 2±29.44 / 3.7±20.77 letters respectively compared to baseline; CRT improved by a mean of 272.4±244.34 / 307.1±305.3 µm, 87.8±178.41 / 240.7±315.4 µm, and 116±207.9 / 259.3±281.7 µm respectively compared to baseline. There was a mean of 5.8 / 7.5 ranibizumab injections at month 12 (range, 4-6 / 5-12 injections). Reading center evaluation showed decreases in the extent of retinal hemorrhage, retinal vein diameter and optic nerve head swelling. No significant difference was noted between patients receiving 0.3mg or 0.5mg ranibizumab. One myocardial infarction and no serious ocular AEs were reported. No eyes progressed to ischemic CRVO.
Ranibizumab was well tolerated and was associated with a marked reduction in macular edema and improvement of visual acuity during the first three months of treatment. Diminution of these initial improvements occurred during the PRN dosing period with the monthly PRN regime faring better than the quarterly dosing schedule.
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