Real life evidence data on intravitreal usage of/treatment with intravitreal aflibercept in Germany: 12-months results of an observational study in nAMD (PERSEUS)

Abstract

Purpose : To evaluate the effectiveness of intravitreal aflibercept injections (IAI) for the total study population as well as the subgroups of treatment-naïve and pretreated patients (who received any pretreatment for neovascular age-related macular degeneration [nAMD]), and to describe follow-up as well as treatment patterns in patients with nAMD for up to 24 months in routine clinical practice in Germany.

Methods : The study enrolled 988 patients and was conducted in ophthalmology clinics and practices throughout Germany to inform on outcomes potentially representative of the current real life treatment patterns. In order to be included in the study, patients had to be diagnosed with nAMD and be treated with IAI in accordance with the European IAI label.
Outcomes following 12 months of treatment are reported here for the whole study cohort (N=847) as well as for subgroups of treatment-naïve (n=451) and pretreated patients (n=396).

Results : Analyzed data at 12 months showed significant improvement in visual acuity (VA), although injection numbers were lower than what would be expected during treatment in strict accordance to the European IAI label.
3.5% of all patients experienced non-ocular treatment-emergent adverse events (TEAE), 8.9% experienced ocular TEAEs. Of all patients, 1.9% had a cataract, 1.1% had conjunctival hemorrhage, and 0.7% had corneal erosion. No cases of endophthalmitis were reported (5211 injections).

Conclusions : After 12 months of treatment with IAI, both treatment-naïve and pretreated patients demonstrated VA gains. VA improvement was higher in treatment naïve patients.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Table 1: Analyzed data after 12 months of treatment with IVA.
* Clinical (i.e. visit for injection only) + Monitoring (i.e. visit without injection) + Combined visits (i.e. injection and monitoring visit)