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B. P. Larsen, 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. 2009;50(13):1921.
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Ranibizumab inhibits new choroidal neovascularization (CNV), while photodynamic therapy (PDT) occludes existing CNV. The purpose of this study is to determine whether combination treatment with ranibizumab and PDT for CNV due to macular degeneration can maintain or improve visual acuity, while decreasing the number of intravitreal injections as compared with ranibizumab monotherapy. To date, we are aware of no other prospective randomized clinical trial comparing ranibizumab monotherapy to combination treatment.
Eyes were randomized to either combination treatment (ranibizumab followed by PDT), or monthly ranibizumab. Eyes in the combination group were retreated if there was evidence of disease activity on angiography or optical coherence tomography. Visual acuity was measured in patients using standard ETDRS charts at baseline and every 3 months.
To date, there were 4 eyes in each group with 12 months follow-up. The mean improvement in visual acuity from baseline to 12 months was 2 ETDRS letters in the combination group (55 letters at baseline to 57 letters at 12 months, Snellen equivalents 20/80), and 14 ETDRS letters in the monotherapy group (53 to 67 ETDRS letters, 20/80 to 20/50). The mean number of ranibizumab injections was 2.75 in the combination group, and 12 in the monotherapy group. The combination group received a mean of 1.25 PDT treatments.
While ranibizumab monotherapy is associated with greater improvement in acuity, combination treatment may result in stable acuity with substantially fewer intravitreal injections.
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