[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.

[Technical aspects of quality assurance for intravitreal injections (IVI)]. / Technische Umsetzung der Qualitätssicherung bei der intravitrealen operativen Medikamenteneingabe (IVOM).

BACKGROUND: Successful quality assurance in intravitreal injection (IVI) of medications requires a complex information technology infrastructure. The main challenges are data availability independent of location, standardization of clinical data, integration of extensive and currently non-standardized image documentation from coherence tomography and compliance with data protection regulations. OBJECTIVE: In this article the technical implementation and data protection principles are reviewed. MATERIAL AND METHODS: Essential aspects in the implementation of quality assurance in the field of IVI are discussed in a systematic approach. RESULTS: In the field of network architectures web-based applications supplemented by local virtual private networks (VPN) and/or other software instances have recently replaced the previously commonly used physical data medium exchange. The standardization of the data, e.g. by converting the visual acuity into logMAR, plays an important role in the collection of treatment data. Multiple non-standardized data formats in optical coherence tomography complicate the general quality assurance structure and comparability of data. CONCLUSION: International standards will probably facilitate this in the near future. Until then individual solutions have to be found on site.

[Social Medical Consequences of Uveitis in Childhood and Adolescence: Results of a Pilot Study]. / Sozialmedizinische Folgen bei Uveitis im Kindes- und Jugendalter: Ergebnisse einer Pilotstudie.

Background Chronic illness - such as uveitis - may lead to socio-economic consequences, and poorer quality of life. Objective To study the influence of uveitis on quality of life and professional development. Material and Methods Prospective evaluation of juvenile patients with uveitis (age < 18 years, classification of uveitis as in Standardization of Uveitis Nomenclature [SUN] criteria, duration of disease ≥ 12 months) seen in a tertiary referral centre. Influence of uveitis on quality of life, recreational activities, educational training and development of severe disability were analysed. Results were correlated to clinical data, and analysed by descriptive statistics. Results 39 patients of 49 (80 %) had anterior uveitis (69.4 % in both eyes), of which 34 (69 %) presented with associated systemic disease (juvenile idiopathic arthritis, n = 28). 33 (80 %) had developed complications caused by uveitis. 15 patients (31 %) had undergone ophthalmic surgery due to these complications. Many patients were treated with conventional (n = 37; 76 %) and biological (n = 18; 37 %) disease-modifying antirheumatic drugs (DMARDs). In 41 % of the cases, quality of life and recreational time (23 %) were markedly reduced. Sick leave from pre-school or school because of uveitis (mean 12.5 days/year; 15 % > 20 days) was recorded in 32 patients (65 %). Uveitis negatively influenced school education in 29 %, and resulted in the necessity to repeat class (n = 3) or to change school (n = 3). Severe disability due to uveitis was found in 30 % of the patients. Conclusions Uveitis in childhood and adolescence may have a substantial impact on social and professional perspectives. Uveitis may result in severe disability even in early childhood.