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D. S. Boyer; Verteporfin PDT Combined With Anti-VEGF Antibiodies for CNV Due to AMD: The Registry of Visudyne AMD Therapy Database. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1809.
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To assess real-world treatment regimens and outcomes of verteporfin (Visudyne) PDT combined with an anti-VEGF antibody (bevacizumab) for patients with choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
: Retrospective analysis of data from patients treated with verteporfin PDT and ≥1 adjunctive intravitreal injection of bevacizumab, entered into a secure Web-accessed database. All patients provided consent and local Institutional Review Boards approved the study. Inclusion criteria: prior treatment of subfoveal CNV due to AMD with bevacizumab administered within ±14 days of verteporfin PDT. The study eye could have been previously treated or treatment-naive. Study eye visual acuity (VA) was captured as Snellen scores and converted to logMAR for statistical calculations. Required follow-up data included vision assessment, dilated eye exam, intraocular pressure check, serious adverse event reporting, and additional treatment(s), if any.
To date, 26 physicians at multiple clinical centers entered data on 510 patients with CNV due to AMD (all lesion types). Of the eligible patients, 369 had ≥1 VA assessment, 239 had VA measured 4 months (±30 days) after the first treatment, and 146 had VA measured 6 months (±30 days) after the first treatment. At baseline, mean VA was 0.960 logMAR (20/200+2); 54% of patients were treatment-naïve. Patients with ≥3 months of follow-up (n=277) had a mean follow-up of 180 days (range 90-478) and received a mean of 0.36 verteporfin PDT treatments and 1.15 anti-VEGF treatments beyond their baseline treatments. At 4 months (n=239), patients gained a mean of 5.4 letters of VA from baseline and at 6 months (n=146) gained a mean of 5.8 letters. At 6 months, patients treated with verteporfin PDT and bevacizumab on the same day gained more VA (n=50; 7.9 letters) than those treated with PDT first (n=30; 5.8 letters) or bevacizumab first (n=66; 4.2 letters). Subgroup analyses of patients who were treatment-naïve with no subfoveal fibrosis at baseline showed better VA outcomes. One patient had a transient ischemic attack 11 days after bevacizumab 1.25 mg that the investigator judged was not related to either treatment.
With a goal of collecting data on at least 1000 patients, this registry may raise hypotheses on whether fewer treatments of verteporfin PDT combined with an anti-VEGF antibody provides a VA benefit comparable to that of monthly ranibizumab (1-2 line improvement), and whether the sequence of administration affects outcomes. Such hypotheses may then be tested in randomized clinical trials.
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