gms | German Medical Science

Purpose: To evaluate the effectiveness of Intravitreal Aflibercept (IVT-AFL) for both the total study population and the subgroups of treatment naïve/pretreated patients (who received any pretreatment for wAMD), and to describe follow-up as well as treatment patterns in patients with wAMD for up to 24 months in routine clinical practice in Germany. Here, results such as visual acuity (VA) changes in naïve wAMD patients after 6 months of treatment are presented.

Methods: The study was conducted in ophthalmological clinics and practices throughout Germany. Interim analysis after 6 months of treatment was performed for the whole study cohort (N=632). Furthermore, the outcomes were compared between the patients treated in strictly regular injection intervals according to the prescribing information (Regular cohort: loading dose of intravitreal injection [IVI] of 2 mg IVT-AFL once a month for 3 months, followed by IVI of 2 mg IVT-AFL every 2 months) and the patients who showed irregularity in the injection intervals (Irregular cohort).

Results: Interim results of 242 treatment naïve patients showed a mean±SD VA improvement of 6.5±16.2 letters. Within the treatment naïve Regular cohort (n=118), mean VA improved by 9.0±15.8 letters (Irregularly treated cohort: 4.2±16.4). Over 6 months, the mean number of injections was 4.2±1.0 in the whole naïve cohort (n=318) and 4.4±0.5 in the naïve Regular cohort (Irregularly treated cohort: 3.9±1.2). Mean time from indication of IVT-AFL treatment by the attending physician to start of treatment was reduced from 24.9±53.5 days (period prior to introduction of IVOM EBM (Einheitlicher Bewertungsmaßstab), a uniform standard for IVI) to 13.4±13.7 days (period after introduction of IVOM EBM). No cases of endophthalmitis were observed in any group (throughout 2571 IVIs). 2.4% of all patients experienced non-ocular treatment-emergent adverse events (TEAE), while 6.0% experienced ocular TEAEs. Ocular TEAEs included conjunctival haemorrhage (1.0% of all patients), corneal erosion (0.8% of all patients), and foreign body sensation in the eyes (0.5% of all patients). Among all patients the rate of arterial thromboembolic events was 0.3%.

Conclusion: VA improvement was observed in treatment naïve wAMD patients after 6 months of treatment with IVT-AFL in a real life clinical setting. Regularity seems to have a greater impact on VA improvement than the mere number of injections, as shown in the comparison between regularly and irregularly treated cohort. The introduction of IVOM EBM significantly reduced the time from indication to initial IVI.