[Prospective noninterventional BLUE SKY study evaluating the efficacy of brolucizumab in treatment-naïve and previously treated patients with neovascular AMD]. / Prospektive nichtinterventionelle BLUE SKY-Studie zur Beurteilung der Wirksamkeit von Brolucizumab bei unbehandelten und vorbehandelten Patienten mit neovaskulärer AMD.

Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is the standard treatment for patients with neovascular age-related macular degeneration (nAMD). In addition to the approved substances ranibizumab (Lucentis®, Novartis) and aflibercept (Eylea®, Bayer), bevacizumab (Avastin®, Roche) is also available. Furthermore, brolucizumab (Beovu®, Novartis) has been approved and has been available in Germany since April 2020. The multicenter, noninterventional prospective BLUE SKY study investigates brolucizumab treatment with different schemes in 600 treatment-naive and pretreated nAMD patients in routine clinical practice over a 24-month period. Besides general patient data, visual acuity and treatment data will be documented. Fluorescein angiography, fundus photography, spectral domain optical coherence tomography and swept-source optical coherence tomography angiography will be performed and analyzed by reading centers. The focus of the analysis will be on the intraretinal and subretinal fluid distribution as well as morphological MNV changes and injection frequency. Also, safety and adverse drug effects of brolucizumab, with a specific focus on inflammatory complications, particularly retinal (occlusive) vasculitis will be evaluated.

[Real-life experiences with Brolucizumab in recalcitrant neovascular age-related macular degeneration]. / Erste Erfahrungen mit Brolucizumab bei neovaskulärer altersabhängiger Makuladegeneration und Therapierefraktärität unter der bisherigen Anti-VEGF-Therapie.

BACKGROUND: Pivotal clinical trials have proven brolucizumab to be a potent intravitreal anti-vascular endothelial growth factor (VEGF) drug in patients with neovascular age-related macular degeneration (nAMD). Therefore, it seems to be a promising drug also in patients with recalcitrant nAMD. This article presents the results of patients who were switched to brolucizumab due to persistent fluid under previous anti-VEGF treatment. METHODS: In this study 21 eyes were retrospectively analyzed in which treatment was switched to brolucizumab due to persistent intraretinal (IRF), subretinal (SRF) and/or sub-retinal pigment epithelium (sub-RPE fluid) fluid despite long-term anti-VEGF treatment. Functional and spectral domain optical coherence tomography (SD-OCT) data were investigated at diagnosis of nAMD (I), at switch to brolucizumab (II), 4 weeks after upload of brolucizumab (III) and at first reactivation of macular neovascularization (MNV, IV). RESULTS: There were no significant changes in fluid distribution between (I) and (II). After upload of brolucizumab (III) a significant reduction of central subfield retinal thickness (CSRT, p = 0.0001), SRF (p = 0.004) and sub-RPE fluid (p = 0.04), but no visual acuity improvement (p = 0.56) were observed. CONCLUSION: Intravitreal brolucizumab treatment can achieve significant reductions particularly of SRF and sub-RPE in patients refractory to previous anti-VEGF treatment. Future studies should further investigate the effects of brolucizumab in patients with recalcitrant nAMD.

[Treatment adherence and effectiveness of anti-Vascular Endothelial Growth Faktor(VEGF) treatment of diabetic macular edema in the clinical routine : Comparison between cooperative and unicentric organization of treatment]. / Therapieadhärenz und Effektivität bei der Anti-Vascular Endothelial Growth Faktor(VEGF)-Therapie des diabetischen Makulaödems im klinischen Alltag : Vergleich zwischen einer kooperativen und einer unizentrischen Organisation der Behandlung.

BACKGROUND: Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is an established method for treatment of diabetic macular edema (DME); however, to ensure the best possible functional results continuous treatment of patients over a long period with regular control visits are necessary. The adherence of patients to the treatment is of great importance for success. METHODS: In order to make implementation of treatment easier for patients, an internet-based referral platform was established to enable the follow-up examination to be performed by an ophthalmologist using spectal domain optical coherence tomography (SD-OCT) close to the patients place of residence. Based on 50 patients the effectiveness of this cooperative treatment (IT-Cooperation) was compared to 50 patients who were controlled in the treatment center for DME patients over a period of 2 years. RESULTS: Patients in the IT-Cooperation group received an average of 6.3 injections in the first year of follow-up compared to the lower number of 5.2 injections for patients attending the treatment center. During the second year the average number of injections decreased to 2.7 (IT-Cooperation) and 2.4 (treatment center). Patients of the IT-Cooperation showed an average of 12.0 control visits in contrast to the average number of 9.6 visits (p < 0.01) for patients attending the treatment center in the first year of observation. This difference between the two groups was significant and was confirmed in the second year of follow-up with 8.3 visits in the IT-Cooperation group compared to 4.4 visits in the treatment center group (p < 0.01). CONCLUSION: The greater number of follow-up examinations close to the patient's place of residence for the IT-Cooperation group significantly improved the quality of treatment adherence in DME patients; however, intensive exchange of information between the ophthalmologist performing the control examinations and the treatment center where the injections were carried out is mandatory.

Comparison of penetration depth in choroidal imaging using swept source vs spectral domain optical coherence tomography.

PURPOSE: To compare signal penetration depth and deep structure-visualization of swept source (SS) and spectral domain (SD)-optical coherence tomography (OCT) with and without enhanced depth imaging (EDI) and B-scan averaging modes. METHODS: Volume scans were obtained from 20 eyes of healthy volunteers by DRI OCT-1, Spectralis using EDI and B-scan averaging, and Cirrus HD-OCT. The signal penetration depth was measured as the distance between the retinal pigment epithelium and the deepest visible anatomical structure at the foveal center. Visibility and contrast of the choroidoscleral junction and of vascular details within the choroid were assessed across the entire volume using an ordinal scoring scale. Outcome measures were compared using paired t-test and rank-sum test. RESULTS: The mean signal penetration depth was 498±114 µm for Spectralis, 491±85 µm for DRI OCT-1, and 123±65 µm for Cirrus; P=0.9708 Spectralis vs DRI OCT-1, P<0.0001 Spectralis vs Cirrus, and P<0.0001 DRI OCT-1 vs Cirrus. Mean ranks for visibility and contrast of the choroidoscleral junction were 3.83 for Spectralis, 3.98 for DRI OCT-1, and 2.00 for Cirrus; and 3.45 for Spectralis, 2.93 for DRI OCT-1, and 1.58 for Cirrus. Mean ranks for visibility and contrast of vascular details were 3.73 (Spectralis), 3.70 (DRI OCT-1), and 2.23 (Cirrus); and 3.53 (Spectralis), 2.05 (DRI OCT-1), and 1.98 (Cirrus). CONCLUSION: Signal penetration depths are similar for SS-OCT and SD-OCT using EDI and frame averaging, and statistically significantly lower without EDI/averaging. Both SD-OCT using EDI/frame averaging and SS-OCT offer excellent visualization capabilities for volumetric imaging of the choroidoscleral interface.