Erste Erfahrungen mit Brolucizumab bei neovaskulärer altersabhängiger Makuladegeneration und Therapierefraktärität unter der bisherigen Anti-VEGF-Therapie

Book, Marius; Ziegler, Martin; Rothaus, Kai; Faatz, Henrik; Gutfleisch, Matthias; Spital, Georg; Lommatzsch, Albrecht; Pauleikhoff, Daniel

doi:10.1007/s00347-021-01474-6

Cited by 8 publications

(4 citation statements)

References 22 publications

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“…The significant reduction in SRF and PED after 1 year of treatment with brolucizumab in our study are comparable to a similar study from ( Book et al, 2021 ), which also reported similar functional and anatomic results with a significant reduction in SRF and PED after 1 year of treatment.…”

Section: Discussionsupporting

confidence: 91%

First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration

et al. 2022

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Purpose: To assess the morphological and functional outcomes within the first year of treatment with intravitreal brolucizumab for refractory neovascular age-related macular degeneration (nAMD).Methods: This retrospective study included 21 eyes from 19 patients with refractory nAMD followed for 12 months. All patients were switched to brolucizumab after treatment with at least two other anti-vascular endothelial growth factors (VEGF). All eyes received 3x brolucizumab 6 mg/0.05 ml intravitreal injections (IVI) monthly as an upload phase. Then eyes received an IVI every 8 weeks with interval adjustment to every 12 weeks if disease activity was not present. Main outcome measures: best corrected visual acuity (BCVA), central macular thickness (CMT) and retinal fluid distribution. In addition, we reported the adverse event rate.Results: The number of previous anti-VEGF IVIs/eye was 36 ± 22 before switching to brolucizumab. BCVA (ETDRS) was 51 ± 16 before treatment and 50 ± 19 at week 52 (p = 0.6). CMT was 374 ± 158 μm before treatment and 298 ± 92 μm at week 52 (p = 0.01). The number of IVIs/eye decreased from 9.6 ± 1.9 IVIs in the last year before switching to 6.4 ± 0.9 IVIs in the first year after switching to brolucizumab (p < 0.001). The rate of eyes with subretinal fluid and pigment epithelial detachment decreased at week 52. Finally, two cases of intraocular inflammation were observed as adverse events.Conclusion: In the first year of treatment, intravitreal brolucizumab was able to stabilize visual acuity with significantly less IVIs in patients with refractory nAMD. It also improved anatomic outcomes in these patients, particularly reducing subretinal fluid and pigment epithelial detachment and subsequently central macular thickness. However, two cases of intraocular inflammation were observed as adverse events.

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Section: Discussionsupporting

confidence: 91%

First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration

et al. 2022

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“…From the 45 real-world studies (50 reports) for inclusion, 26 studies (31 reports) described at least 10 brolucizumab-treated eyes, and are thus included in the main descriptive summary (Tables 1-3; Tables S1-S3) (Abdin et al, 2021;Aziz et al, 2021;Baumal et al, 2020;Bilgic, Kodjikian, March de Ribot, et al, 2021;Bilgic, Kodjikian, Srivastava, et al, 2021;Book et al, 2022;Bulirsch et al, 2022;Chakraborty et al, 2021;Cristian et al, 2021;Enríquez et al, 2021;Fossataro et al, 2021;Fukuda et al, 2021;Haensli et al, 2021aHaensli et al, , 2021bHamou et al, 2021;Hussain, 2021;Kilani et al, 2021;Maruko et al, 2021;Matsumoto et al, 2021;Montesel et al, 2021;Rave et al, 2021;Reyes-Capo et al, 2021;Rispoli et al, 2021;Sharma, Kumar, et al, 2021;Sharma, Rave, et al, 2021;Sudhalkar et al, 2021;Walter & Saba, 2021aWitkin et al, 2020Witkin et al, , 2021. A further 19 studies (19 reports) describing fewer than 10 brolucizumab-treated eyes are included in Table S4.…”

Section: Search Resultsmentioning

confidence: 99%

Efficacy and safety of brolucizumab in age‐related macular degeneration: A systematic review of real‐world studies

Baumal

Sørensen

Karcher

et al. 2022

Acta Ophthalmologica

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Intravitreally injected anti-vascular endothelial growth factor (anti-VEGF) agents are first-line treatment for neovascular age-related macular degeneration (nAMD).Phase 3 trials demonstrated non-inferiority of anti-VEGF therapy with brolucizumab compared with aflibercept in best corrected visual acuity (BCVA) gains, with superior anatomical outcomes after brolucizumab. The purpose of the review was to summarize real-world efficacy and safety data on brolucizumab in patients with nAMD. The review protocol was registered with PROSPERO (ID: CRD42021290530). We conducted systematic searches in Embase, Medline and key ophthalmology congress websites (19 October 2021). Original reports of efficacy and/or safety in patients receiving brolucizumab to treat nAMD in clinical practice were eligible. The descriptive summary includes reports describing at least 10 brolucizumab-treated eyes. In total, 2907 brolucizumab-treated eyes from 26 studies were included. Outcomes were available for treatment-naive eyes (six studies), eyes switched to brolucizumab from other anti-VEGFs (16 studies), and/ or treatment-naive and switch eyes combined (eight studies). Follow-up time points ranged from 4 weeks to 1 year post-brolucizumab initiation. For BCVA, significant improvements compared with brolucizumab initiation were reported in four of six studies in treatment-naive eyes (mean BCVA improvement, range: +3.7 to +11.9 EarlyTreatment Diabetic Retinopathy Study [ETDRS] letters) and in three of 12 studies in switch eyes (range: +9.0 to +15 ETDRS letters) (all p < 0.05); remaining studies reported no significant post-brolucizumab BCVA changes. For central subfield thickness (CST), improvements post-brolucizumab initiation were reported in all six studies in treatment-naive eyes (mean CST improvement, range: −113.4 to −150.1 μm) and in eight of 11 studies in switch eyes (range: −26 to −185.7 μm) (all p < 0.05). The 14 studies reporting on intraretinal, subretinal and/or total fluid observed improvements post-brolucizumab initiation. The four studies comparing treatment intervals observed extension of the interval between injections after switching to brolucizumab from other anti-VEGFs. Incidence of intraocular inflammation ranged from 0% to 19%. In conclusion, real-world efficacy and safety data concur with brolucizumab pivotal trials. Additionally, reduction of disease activity in anti-VEGF switch eyes was demonstrated by fluid reduction and/or visual acuity gain, along with prolongation of the interval between injections.

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“…[15][16][17] Despite those adverse events, several recent studies have reported favourable anatomical responses following a shift to brolucizumab or switch in refractory nAMD. 18,19 Currently, the long-term morphological macular changes and fluid dynamic changes of brolucizumab in patients with TN nAMD and RT are undetermined.…”

Section: Discussionmentioning

confidence: 99%

“…Previously published studies were directed towards brolucizumab use as a switch or shift treatment in refractory nAMD but these studies were limited by short follow-up periods and individual treatment protocols. [18][19][20] In our study, we applied the HAWK and HARRIER protocols for better comparability with large prospective multicentre trials. For instance, in the SHIFT study from Bulirsch et al after administrating a single brolucizumab injection, patients were then treated directly subsequently with a treat and extend protocol.…”

Section: Discussionmentioning

confidence: 99%

Morphological Macular Changes Under Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration Refractory to Previous Anti-VEGF Treatment Compared with Treatment-Naive Eyes

William¹,

Verma-Fuehring²,

Kuehnel³

et al. 2023

OPTH

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To evaluate the morphological macular changes and fluid dynamics under brolucizumab treatment in eyes refractory to previous anti-vascular endothelial growth factor (anti-VEGF) treatment for neovascular age-related macular degeneration (nAMD) compared with treatment-naive eyes. Methods: Retrospective study of all eyes treated with brolucizumab for nAMD between 2020 and 2021 with a fixed injection regimen and one year follow-up. Treatment-naive eyes (TN) were compared with eyes refractory to previous treatment with bevacizumab, ranibizumab, or aflibercept (RT). The primary outcome measure was change of best-corrected visual acuity (BCVA). Secondary outcome measures included foveal central thickness (FCT), presence of intra-or subretinal fluid (IRF, SRF) and presence of pigment epithelial detachment (PED) at any time point during treatment in both groups. Results: Seventeen TN eyes and 17 RT eyes were included. Mean BCVA and mean FCT in TN eyes had significantly improved after 3 months and continued to improve during treatment (p<0.05 and p=0.001, respectively). In RT eyes, mean BCVA did not change significantly while mean FCT had improved after 3 months of treatment and remained stable thereafter. SRF or PED were more frequent in RT eyes compared with TN eyes (p=0.003 and p=0.005, respectively). Conclusion: After 3 months of treatment, the BCVA increased significantly only in TN eyes, while the FCT was significantly reduced in both groups. IRF appears to be similarly seen in both groups after the loading phase; however, SRF and PED appear to be more frequent in the RT eyes compared with TN eyes.

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Erste Erfahrungen mit Brolucizumab bei neovaskulärer altersabhängiger Makuladegeneration und Therapierefraktärität unter der bisherigen Anti-VEGF-Therapie

Cited by 8 publications

References 22 publications

First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration

First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration

Efficacy and safety of brolucizumab in age‐related macular degeneration: A systematic review of real‐world studies

Morphological Macular Changes Under Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration Refractory to Previous Anti-VEGF Treatment Compared with Treatment-Naive Eyes

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