[Prospective noninterventional BLUE SKY study evaluating the efficacy of brolucizumab in treatment-naïve and previously treated patients with neovascular AMD].
H FaatzN FeltgenM GutfleischB Heimes-BussmannT U KrohneS LiakopoulosR LieglA LommatzschP MussinghoffM RehakS Schmitz-ValckenbergG SpitalB StanzelF ZiemssenB HägeleC JunkesM PorstnerJ VögelerB GmeinerDaniel PauleikhoffPublished in: Die Ophthalmologie (2022)
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.
Keyphrases
- age related macular degeneration
- optical coherence tomography
- vascular endothelial growth factor
- clinical practice
- diabetic retinopathy
- chronic kidney disease
- adverse drug
- machine learning
- oxidative stress
- end stage renal disease
- computed tomography
- electronic health record
- clinical trial
- magnetic resonance imaging
- magnetic resonance
- combination therapy
- ejection fraction
- patient reported outcomes
- hiv infected
- big data
- drug induced
- case report
- antiretroviral therapy