A Canadian Registry Of Lucentis Treatment To Collect Effectiveness And Safety Data In Patients With Neovascular Age-related Macular Degeneration Over 36 Months (LENS): Findings From A 12-month Interim Analysis

Abstract

Purpose: : This Canadian registry was established in 2009 to evaluate the real-life effectiveness, safety and quality of life (QoL) of Lucentis treatment in patients with wet Age-related Macular Degeneration (AMD).The registry follows patients for 36 months.

Methods: : A total of 184 Canadian patients with wet AMD who receive intravitreal Lucentis treatment were enrolled in the registry. Lucentis treatment was administered by the physicians according to the Canadian Product Monograph in real-life practice settings. An interim analysis was performed once 50% of the total sample had completed 12 months of Lucentis treatment; these results are reported here. Main outcomes include mean change from baseline to month 12 in Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT), proportion of patients gaining 15 letters or more from baseline to month 12, and Visual Functioning Questionnaire (VFQ)-25.

Results: : In the 92 evaluable patients who completed the 12 months of Lucentis treatment, the mean (±SD) age is 78.5(±8.7) years, and 67% are female. Mean baseline BCVA and CRT were 40.2 (±17.83) ETDRS letters and 359.4 (± 112.67) µm, respectively. At 12 months, the mean change from baseline in BCVA was an improvement of 6.1 (95% CI: 2.9, 9.3) ETDRS letters (n=62). The mean change from baseline in CRT was a decrease of 104.6 (95% CI: 127.6, 81.7) µm (n=88). The percentage of patients gaining 15 letters or more was 25.8 %. The mean number of Lucentis treatments administered during the first year was 8.92 (±2.68) injections per patient. The mean change in VFQ-25 composite score was an increase of 3.6 (95% CI: 1.0, 6.2) at month-3 and maintained at month-12. Serious adverse events (SAEs) are presented for all patients in the registry administered at least one dose of Lucentis (n=183). Twenty patients (10.9%) experienced at least one SAE.

Conclusions: : The 12 month interim analysis showed that the real-life treatment of Lucentis provided comparable visual improvement to the published data, suggesting that Lucentis is an effective and safe therapy for the disease in real-life settings.

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • retina