Session Title: Free Paper Session 3: AMD I
Session Date/Time: Thursday 07/09/2017 | 08:30-10:00
Paper Time: 08:54
Venue: Room 118
First Author: : C.Framme GERMANY
Co Author(s): : J. Korobelnik R. Finger L. Kodjikian
PERSEUS and RAINBOW are the first studies to analyze the real world use of intravitreal aflibercept injections (IVT-AFL) in patients newly diagnosed with neovascular macular degeneration (nAMD) in Germany and France, respectively. The aim of these studies was to assess the impact of regular treatment approach with IVT-AFL and the impact of loading doses on visual acuity (VA) after 12 months of treatment under clinical routine conditions in 2 different healthcare systems. Different approaches were applied to analyze both studies. An integrated analysis of pooled data from both studies is currently in course of preparation.
PERSEUS and RAINBOW are non-controlled, multicentre, observational cohort studies conducted in ophthalmological clinics and practices throughout Germany and France respectively. Patient recruitment was conducted prospectively in PERSEUS. However, the recruitment of patients was conducted both retrospectively and prospectively in RAINBOW.
PERSEUS included patients diagnosed with nAMD who received treatment with IVT-AFL in accordance with European IVT-AFL product labeling. In total, 847 patients were included in the 12-month analysis. The 12-month results are presented from the anti-VEGF treatment-naïve cohort (n=451) which were stratified based on the regularity of treatment: the regular cohort included patients who received a loading dose defined as three monthly injections of 2 mg IVT-AFL, followed by 2 mg IVT-AFL every 2 months, and the irregular cohort included patients who didn’t meet the criteria for regular cohort. RAINBOW included treatment-naïve patients diagnosed with nAMD receiving treatment with 2 mg IVT-AFL in accordance with European IVT-AFL product labeling. In total, 502 patients were included in the 12-month analysis with available VA data at month 12 for 353 patients. A subgroup of 284 patients received 3 loading doses within 90 days (regular cohort). Analyses of both studies included baseline characteristics, VA change, number of injections as well as number of visits.
PERSEUS: Baseline mean±SD age was 77.4±7.7 years, baseline VA was 53.1±18.2 letters. After 12 months, when analyzing the regular (33%) vs. the irregular cohort, mean VA improvement was 8.1±17.7 vs. 4.2±17.0 letters (total naïve cohort: 5.5±17.3). The proportion of patients with VA ≥70 letters increased from 22.9% to 46.0% vs. 24.7% to 39.7%. A gain of ≥15 letters was observed in 32.5% vs. 28.2% of patients. A loss of ≥15 letters was observed in 6.4% vs. 14.3% of patients. For all naïve patients, the mean number of injections was 5.8±2.2, mean number of visits was 8.9±4.1. RAINBOW: baseline mean age was 79.7±7.8 years, baseline VA was 56.7±18.2 letters. At month 12, mean VA improvement was 5.5±15.0 (regular cohort [80.5%]: 6.8±14.5). 45.9% of all patients achieved a VA of ≥70 letters (baseline: 30.5%). A gain of ≥15 letters was observed in 25.2% of all patients (regular cohort: 28.9%) A loss of ≥ 15 letters was observed in 4.8% of all patients (regular cohort: 3.5%). Mean number of injections was 6.2±2.0, mean number of visits was 9.7±1.9. In the total cohorts, treatment-related treatment-emergent adverse events occurred in 3.4% (PERSEUS) and 1.9% (RAINBOW) of patients. No endophthalmitis cases were observed in either study.
Both the PERSEUS and the RAINBOW study are the first real world observational studies to analyze results of IVT-AFL in nAMD in Germany and France, respectively. In both healthcare systems within a 12-month treatment period, patients benefited most when 3 IVT-AFL loading doses were given and when a loading phase was combined with IVT-AFL in regular injection intervals, as opposed to irregular treatment. The incidence of adverse events was consistent with the known safety profile of IVT-AFL in nAMD.