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AC HoVAM Study Group; The VAM Study: An Open-label, Multicenter, Safety Study of Verteporfin Therapy for Predominantly Classic Subfoveal Choroidal Neovascularization (CNV) Due to AMD . Invest. Ophthalmol. Vis. Sci. 2002;43(13):979.
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Purpose: To report the results of the Verteporfin in AMD (VAM) Study, which was conducted to provide clinical experience and monitor safety of verteporfin (Visudyne®, Novartis AG) therapy prior to commercial availability. Methods: The open-label study was conducted at 222 clinical centers in North America. Main eligibility criteria were: age ≥40 years, subfoveal predominantly classic lesions due to AMD, and a corrected distance Snellen visual acuity equivalent of 20/40 to 20/200. All patients received verteporfin therapy at the initial visit, and were to be retreated at 3-monthly follow-up visits if fluorescein leakage was seen on angiography. The effect of verteporfin therapy on corrected distance visual acuity was measured as a safety outcome, and the incidence of adverse events (AEs) was monitored by patient self-reporting, direct questioning, telephone questioning and physician evaluation. The study was discontinued when verteporfin therapy became commercially available approximately 9 months after the study was initiated. Results: Of the 4435 patients enrolled, 4051 (91%) were still ongoing at the time the study was discontinued. A total of 6701 treatments were given: most patients received only 1 treatment before verteporfin therapy became commercially available. The proportion of patients receiving retreatment decreased from 1906 (47%) of 4041 patients at the month 3 examination to 11 (3%) of 411 patients by the month 9 examination. Compared with baseline, visual acuity improved or remained the same (defined as no movement between corrected visual acuity categories compared with baseline) in 59% of patients at the month 3 examination, 50% at the month 6 examination, and 46% at the month 9 examination. The overall incidence of AEs was 16%, regardless of association with treatment; most of these AEs (81%) were mild or moderate. Only 7% of patients experienced AEs considered to be associated with treatment. Photosensitivity reactions were reported by 2 patients, and 14 patients (0.3%) reported infusion-related back pain. Only 35 patients (0.8%) experienced a serious ocular AE in the treated eye. The most frequently occurring serious AE was acute severe vision decrease (loss of ≥4 lines of visual acuity within 7 days of treatment) (0.7%). Conclusion: The VAM Study confirmed the positive safety profile of verteporfin therapy, as established in the TAP Investigation, and presents a favorable safety profile outside the confines of a controlled clinical trial.
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