Initial Pro Re Nata Brolucizumab for Exudative AMD: The PROBE Study

Abstract

The present study aimed to determine the efficacy and safety of pro re nata (PRN) intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) without a loading dose in the real-world setting. The PROBE study (Pro Re Nata Brolucizumab for Exudative AMD) is a retrospective, observational, multicentric study that included 27 treatment-naïve patients (27 eyes) with neovascular AMD who received PRN brolucizumab therapy with the treatment interval being at least 8 weeks, should the need for a second consecutive injection arise. The primary outcome measure was changed to best-corrected visual acuity (BCVA) over time. Secondary outcome measures included the determination of change in central subfield thickness (CST) and complications. The mean follow-up was 11.2 ± 1.2 months. The mean baseline and final BCVA were 57.4 ± 4.5 letters and 65.3 ± 3.12 letters, respectively (p = 0.014). The mean gain in letters at the end of follow-up was 7.8 ± 3.5 letters. There was a significant decrease in CST at the end of the follow-up period (p = 0.013). Patients received a mean of 2.2 ± 0.9 injections (in addition to the first mandatory injection) during the follow-up period. There were no adverse events noted. In conclusion, initial PRN brolucizumab for exudative AMD without a loading dose demonstrated significant visual improvement and no adverse events.

Age-Related Macular Degeneration: New Insights in Diagnosis, Treatment, and Prevention

“…The first real-world studies of brolucizumab for AMD seem to confirm these data [18,19], both in treatment-naïve eyes and when switching from another therapy [18,20]. However, the increased, although still rare, the occurrence of intraocular inflammatory adverse events (which can lead to vascular occlusion and vision loss) for this new molecule means a change in the treatment paradigm toward injections that are more spaced out is likely, helped by its improved efficacy [21]. In the coming years, the therapeutic arsenal will be totally transformed by numerous molecules in development [22], and the discovery of new therapeutic targets [23], with the aim of reducing the therapeutic burden and improving visual outcomes.…”

Brolucizumab for the Treatment of Degenerative Macular Conditions: A Review of Clinical Studies

“…Results revealed significant mean BCVA increase, CST reduction and fluid resolution in approximately 75% of eyes after two injections. 63 The same research team suggested that intravitreal brolucizumab may be beneficial for nAMD patients who develop an RPE tear, either as primary or switch therapy. 64 …”

“… Bilgic et al, The PROBE Study. 63 2021 Retrospective, observational, multicentre 27 (27) 1. Mean BCVA showed notable improvement from 57.4 ± 4.5 ETDRS letters at baseline to 65.3 ± 3.12 letters at the final examination (p = 0.014).…”

“…20 Bilgic et al designed a study in an effort to estimate the efficacy of pro re nata (PRN) brolucizumab for the treatment of exudative AMD (PROBE study). 63 Study population included treatment-naïve patients that received PRN intravitreal brolucizumab without a loading dose at 8-week treatment intervals. Results revealed significant mean BCVA increase, CST reduction and fluid resolution in approximately 75% of eyes after two injections.…”

“…Results revealed significant mean BCVA increase, CST reduction and fluid resolution in approximately 75% of eyes after two injections. 63 The same research team suggested that intravitreal brolucizumab may be beneficial for nAMD patients who develop an RPE tear, either as primary or switch therapy. Montesel et al presented the short-term outcomes of brolucizumab therapy in treatment-naïve and switch patients with nAMD, following the treatment protocol of HAWK and HARRIER studies.…”