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H.A. Strong, Visudyne Registry Database Study Group; The Visudyne Registry Database: Collecting Data from Patients Treated with Verteporfin Therapy for CNV due to AMD . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3146.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To assess treatment patterns and outcomes for patients with CNV due to AMD treated with photodynamic therapy with verteporfin (Visudyne®, Novartis AG), using data from the internet–based, secure Visudyne Registry database. Methods: Patients undergoing verteporfin therapy for CNV signed an Institutional Review Board–approved informed consent form, and data were entered into the database. Baseline and follow–up data on age; gender; cause of CNV; previous treatments; lesion greatest linear dimension (GLD) on the retina, location, and percent classic of the CNV; lesion components; use of adjuvant therapies; and treatment parameters were collected. Results: 1458 verteporfin–treated AMD patients (mean age 79 years) were analyzed: 95% Caucasian and 62% women. Mean baseline visual acuity (VA) was 20/200+1, with 41% worse than 20/200 and over 20% worse than 20/400. Mean baseline GLD was 3278 µm (approx. 4 disc areas): 92% were subfoveal and 88% predominantly classic (where ≥50% of the total lesion area is classic CNV). 283 patients who had a follow–up visit 360 +/– 45 days after starting verteporfin therapy were seen an average of 6.7 times and received 3.1 treatments. Patients were stratified into 2 groups: better VA (baseline vision ≥20/200, mean 20/100+2) and poorer VA (vision <20/200, mean 20/500–2). At the 1 year follow–up evaluation, mean change in VA was –13.8 letters and +5.9 letters, respectively. Conclusions: Patients with poorer baseline VA had a mean VA improvement of 1 line; however, patients with better baseline VA had an average loss of almost 3 lines. Comparison of these outcomes with published randomized clinical trial outcomes needs to be made with caution for a variety of reasons, including potentially different patient populations for known (visual acuity, lesion size, lesion composition) and unknown factors and the effect on vision outcomes; different methods of measuring visual acuity; and, possibly a lower number of treatments within the first year (3.1 versus 4.0 in TAP). However, once the database becomes more robust it should provide a valuable tool for evaluating how various baseline factors and practice patterns, including adjunctive therapies, could affect outcomes.
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