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B. P. Larsen, M. J. Davis, S. S. Mudvari, M. W. MacCumber, P. T. Merrill; Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-Based Retreatments (CLOVER) Trial. Invest. Ophthalmol. Vis. Sci. 2010;51(13):902.
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Ranibizumab inhibits new choroidal neovascularization (CNV) while photodynamic therapy (PDT) occludes existing CNV. Monthly intravitreal injections of ranibizumab have been shown to stabilize or improve vision. The purpose of this study was to determine whether combination treatment can also maintain or improve visual acuity, while decreasing the number of intravitreal injections required.
In this prospective, randomized, open-label study, eyes with CNV due to ARMD were randomized to either combination treatment (ranibizumab followed by PDT), or monthly ranibizumab. Visual acuity was measured in patients using standard ETDRS charts at baseline and every three months. Optical coherence tomography (OCT) was obtained monthly, and fluorescein angiography (FA) was performed every three months. In the combination group, repeat monthly ranibizumab and/or quarterly PDT was based on evidence of active disease as evidenced by OCT, FA, or visual acuity change.
To date, there were 5 eyes in each group with 12 months follow-up. On average, visual acuity in the combination group improved one ETDRS line, from 20/80 (Snellen equivalent) at baseline to 20/63 at 12 months. In the monotherapy group, average acuity improved three lines, from 20/100 at baseline to 20/50 at 12 months. The change in visual acuity was not significantly different between the groups (p=.095, Mann-Whitney U). There were significantly fewer ranibizumab injections in the combination group than in the monotherapy group (mean 2.6 vs. 13, p=.008, Mann-Whitney U). On average, eyes in the combination group received 1.4 PDT treatments. Three eyes (60%) in the combination group remained stable over the 12 months with no retreatments.
Both combination treatment and monthly ranibizumab monotherapy resulted in visual improvement. Eyes receiving combination treatment required significantly fewer intravitreal injections. Combination treatment may allow patients similar visual results, while decreasing the treatment burden and risks associated with monthly intravitreal injections.
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