The Visudyne Registry Database:
Collecting Data from Patients Treated with Verteporfin Therapy for CNV
due to AMD
Paul B. Griggs, M.D.1 and the
Visudyne Registry Database Study Group
(1Seattle, Washington, USA)
Purpose: To assess treatment patterns and outcomes for
patients with choroidal neovascularization (CNV) due to age-related macular
degeneration (AMD) treated with photodynamic therapy with verteporfin
(Visudyne®, Novartis AG), using data from the internet-based, secure
Patient InSight 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: A total of 1458 verteporfin-treated AMD patients (mean age 79
years) was 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 ³50% of the
total lesion area is classic CNV). The 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 ³20/200, 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 VAimprovement
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 affect on vision outcomes; different methods of measuring visual acuity;
and, possibly a lower number of treatments within the first year (3.1
versus 4 in TAP). However, as 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.