Author: Katrin Lorenz
Co-authors: Christos Haritoglou, Vincent Hoppenreijs, Salvatore Grisanti, Peter Geuking, Matthias Iwersen, Bettina Müller, Eric Stork, Focke Ziemssen
Abstract
Purpose:The PACIFIC study aims to describe the current state of ranibizumab patient care across several indications including neovascular age-related macular degeneration (nAMD), diabetic macula edema, retinal vein occlusion and other choroidal neovascularization in Germany, the Netherlands and Switzerland, and will therefore reflect country and site variability of treatment practices. Here, we will focus on the therapy management of the nAMD subgroup.
Setting/Venue:
PACIFIC is a 24-months, prospective, multicenter, observational, single-arm European study to evaluate ranibizumab 0.5 mg treatment patterns in real‐life conditions. From June 2015 to March 2019, 4.948 patients were enrolled in 218 clinical sites across Germany, the Netherlands, and Switzerland.
Methods:
PACIFIC monitors anti-VEGF treatment with ranibizumab 0.5 mg in treatment-naïve and pre-treated patients within an observational period for up to 24 months. Treatment, diagnosis, and therapy monitoring are performed according to routine clinical practice and at the investigator’s discretion. Here we report on the management of 1.590 treatment naive (TN) versus 1461 pretreated (PT) patients within the nAMD subgroup.
Results:
Age (78.2(8.4)/79.6(8.0) years (standard deviation)) as well as female gender (60.4%/58.6%)) were comparable for TN and PT patients. At baseline, visual acuity (VA) was 54.0 letters (lts) (mean, 95% Confidence Interval (95%CI) [53.0; 55.0] lts) in TN patients and 58.0 (95%CI [56.9; 59.0] lts) in PT patients. The mean time between first VA visit and first injection was 8.9 (13.9) and 8.2 (15.7) days regarding TN and PT patients, respectively. Visual acuity improved by at least 15 lts in 27.0% TN and in 10.4% PT patients after 12 months and in 26.6% TN and in 9.8% PT of patients after 24 months. At the end of the observational period, the regimen used corresponded to the monitor-and-extend (ME) regimen for 87.6% TN and 82.2% PT patients. Only 11.5% TN and 17.2% PT patients treated according to a treat-and-extend (TE) regimen showed the best VA development within this group gaining 7.9 and 1.1 ETDRS letters (lts) for TN and PT patients respectively. This correlates with the comparatively highest number of ranibizumab injections administered after 24 months of observation (16.9 (3.0) TN/16.4 (3.0) PT) and the frequently performed functional (10.8 (5.6) TN/10.3 (5.7) PT) and morphological (8.1 (5.8) TN/6.8 (5.2) PT) examinations.
Conclusions:
In the PACIFIC study, treatment in the subgroup of nAMD patients was most promising applying the TE regimen. In particular, TN patients gained benefit. Both injection number and functional and morphological examinations were most frequent in this group. In contrast, ME was the preferred study treatment regimen. The results of this 2-year observational study show that nAMD patients with a TE regimen have a low risk of undertreatment, which had clear advantages over the most common monitoring approach (with fewer injections).
