Abstract Vitreoretinal Symposium Frankfurt / Marburg 2007
3rd scientific session: Pharmaco-Surgery and beyond


28. Combination Therapy of CNV Caused By AMD with Verteporfin PDT and Bevacizumab:
The Registry of Visudyne® AMD Therapy Database

Paul B. Griggs for the RVT Investigator Group (Seattle)

Purpose: To assess real-world treatment regimens and outcomes for patients with CNV caused
by AMD treated with a combination of verteporfin (Visudyne) PDT and intravitreal bevacizumab.
Methods: Retrospective analysis of patients treated with verteporfin PDT and at least 1 intravitreal injection of bevacizumab. Physicians entered data into a secure Web-accessed database after obtaining patient consents and IRB approvals. Inclusion criteria: prior treatment of subfoveal CNV (classic, occult, or minimally classic) due to AMD with bevacizumab administered within ±14 days of verteporfin PDT. The study eye could have been previously treated or treatment naive. 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, data were entered for 922 patients with at least 3 months of follow-up. At baseline, mean VA was 0.944 logMAR (20/176); 55 % of patients were treatment-naïve. Patients had a mean follow-up of 8.4 months (range 3.0-19.2 months) and received a mean of 0.4 verteporfin PDT treatments and 1.5 bevacizumab treatments beyond their baseline treatments. At 8 months patients (n=465) gained a mean of 6.7 letters of VA; treatment-naïve patients (n=245) gained a mean of 9.6 letters. The order of treatment did not substantially affect the VA outcome at 2 months (the most relevant time point for assessing the effect of different treatment sequences). Seven patients experienced serious adverse events (3 ocular and 4 non-ocular events). All but 2 events were judged not related to either treatment; one instance of retinal tear and one of iritis with reduced visual acuity were judged related to intravitreal bevacizumab administration.
Conclusions: With a goal of collecting data on at least 1000 patients, this registry may raise hypotheses on whether fewer combination treatments of verteporfin PDT and an anti-VEGF antibody provide 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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