Abstract
Purpose::
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).
Methods::
: 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.
Results::
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.
Conclusions::
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.
Keywords: age-related macular degeneration • photodynamic therapy