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.
ABSTRACT
The aim of the present study was to determine the efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) in the real-world setting. The REBA study (real-world experience with brolucizumab in wet AMD) was a retrospective, observational, multicentric study that included 78 consecutive patients (105 eyes), with neovascular AMD, who received brolucizumab therapy. Both treatment-naive and switch-therapy patients were included. Switch therapy was based either on fluid recurrence, fluid recalcitrance, or inability to extend beyond q4/q6. All relevant data were collected. The primary outcome measure was change in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included determination of change in central subfield thickness (CST) and complications. The mean baseline BCVA was 49.4 ± 5.4 letters and 40 ± 3.2 letters, and corresponding mean BCVA gain was +11.9 ± 3.9 letters (p = 0.011) and +10.4 ± 4.8 letters (p = 0.014) in the treatment-naive and switch-therapy groups, respectively. The change in CST was significantly decreased in the treatment-naive (p = 0.021) and the switch-therapy (p = 0.013) groups. The mean follow-up was 10.4 months in both groups. One patient in the switch-therapy group developed vascular occlusion and another a macular hole after the fifth brolucizumab injection. Both patients recovered uneventfully. In conclusion, patients showed a very good anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Two significant untoward events were noted.
ABSTRACT
AIMS: To evaluate the efficacy and safety of intravitreal dexamethasone implant (DEX-implant) for diabetic macular edema (DME) in real-life practice with an extended follow-up for up to 5 year. METHODS: This multicentric retrospective study reviewed 227 eyes of 152 patients with DME treated by DEX-implant. Main outcome measures included changes in best corrected visual acuity (BCVA), central macular thickness (CMT), time to retreatment and incidence of adverse effects. RESULTS: The mean number of DEX-implant received by patients was 2.6 (± 2.2) with a mean (SD) follow-up of 20.1 (± 15.8) months, median [IQR] 15.8 [7.4-30.1]. The mean time of retreatment was 6.9 months. The mean maximal BCVA gain during follow-up was 12.3 (± 12.7) letters. A gain of ≥ 5, ≥ 10 and ≥ 15 letters from baseline BCVA was obtained for 71.8%, 48.9% and 34.8% of eyes, respectively. A total of 62.6% of eyes presented a significant anatomical response (decrease of CMT ≥ 20%), and DME was resolved (absence of cystoid macular spaces on OCT) in 37% of cases at the end of the follow-up. A transient increase in intraocular pressure ≥ 25 mmHg occurred in 14.1% of eyes, and cataract surgery was performed for 49.1% of the phakic eyes during the follow-up. Four eyes developed a proliferative diabetic retinopathy. CONCLUSION: This large cohort study showed favorable long-term outcomes when using DEX-implant, which provides substantial long-term benefits in the treatment of DME in real life.
