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K. W. Small, R. Silva-Garcia, Registry Investigator Groups; Treating Wet AMD With Verteporfin PDT in Triple or Double Combination Therapy: Results of Two Visudyne® Registry Databases. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1925.
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To assess real-world treatment outcomes of verteporfin PDT (vPDT) as double (with an anti-VEGF agent) or triple (with an anti-VEGF agent plus a corticosteroid) therapy in patients with CNV due to AMD. Results from these registries may provide a basis for further investigations to address questions such as: does vPDT combined with an anti-VEGF antibody (with or without steroid treatment) provide a visual acuity (VA) benefit similar to monthly ranibizumab, with acceptable safety, but with fewer treatments?
Retrospective analysis of data from 2 registries. Registry 1: patients received bevacizumab within ±14 days of vPDT. Registry 2: patients received either (1) ranibizumab within ±14 days of vPDT, or (2) vPDT combined with ranibizumab or bevacizumab and a corticosteroid, where all 3 components were delivered within 14 days of each other. Physicians entered data into secure Web-accessed databases. Inclusion criteria: prior treatment of subfoveal CNV due to AMD administered at least once as described. Follow-up data: visual acuity (VA) assessment, dilated ocular examination, intraocular pressure check, serious adverse event reporting, and additional treatment(s), if any.
In Registry 1 and 2, respectively, 1073 and 539 patients had at least 6 months of follow-up, and patients had mean baseline VA of 0.967 logMAR (20/185) and 0.928 logMAR (20/170). A mean of 0.6 and 0.4 vPDT retreatments and 2.2 and 2.0 anti-VEGF retreatments were given over a mean follow-up period of 15.0 and 11.2 months, respectively. By 12 months of follow-up, patients gained a mean VA of 6.0 letters (n=701) and 5.7 letters (n=248), respectively. In the 2 registries combined, 11 ocular and 36 non-ocular serious adverse events were reported as of April 2008. Most events (42/47, 89%) were judged by investigators as not related to any treatment, while 4 of the ocular events were judged related to bevacizumab treatment alone and 1 ocular event was judged related to both PDT and bevacizumab treatment.
Results from the over 1600 patients in these registries provide preliminary support that vPDT combined with an anti-VEGF agent (with or without corticosteroid treatment) appears to provide a VA benefit similar to monthly ranibizumab, with acceptable safety, but requiringfewer retreatments. Randomized controlled trials are underway that may answer questions raised by these analyses.
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