A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
RAZORBILL is an observational, multicenter, multinational, open-label, study designed
 primarily to investigate the influence of automated OCT image enrichment with segmentation
 information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs
The main goal of this study is to assess to what degree disease activity assessment is
 influenced and supported by the enrichment of OCT images with segmentation information (i.e.
 by identification, highlighting and quantification of pathological fluid compartments
 associated with neovascular activity).

 The study comprises a prospective data collection phase and a retrospective analysis of OCT
 images phase. The prospective observation period per patient will be up to 12 months.

 The study will include 720 patients (naïve patients and patients who have been pre-treated
 with licensed anti-VEGFs not more than 3 years) being treated for nAMD with brolucizumab,
 ranibizumab, or aflibercept according to the respective drug label. Patients will be enrolled
 at approximately 20 centers across 6 countries.
Inclusion Criteria:

 -  Diagnosis of nAMD

 -  Male and Female patients with ≥40 years of age at index

 -  Receipt of at least one injection of brolucizumab, ranibizumab or aflibercept during
 the recruitment period

 -  Signed written informed consent

 -  Patients for whom a therapy with brolucizumab, ranibizumab or aflibercept is medically
 indicated according to the respective label

 -  Intraretinal and/or subretinal fluid affecting the central subfield of the study eye
 at screening

 Exclusion Criteria:

 -  Patients treated for any other retinal disease than nAMD within 6 months prior to the
 index date (e.g. patients treated for retinal vein occlusion, diabetic macular oedema,
 myopic CNV, and have diagnoses of diabetes-related macular degeneration)

 -  Central subfield of the study eye affected by fibrosis or geographic atrophy or total
 area of fibrosis >50% of the total lesion in the study eye at screening

 -  Any active intraocular or periocular infection or active intraocular inflammation in
 either eye at index date

 -  Patients who have been on anti-VEGF treatment for longer than 3 years (before index
 date)

 -  Patients who have any contraindication and are not eligible for treatment with the
 chosen anti-VEGF treatment as according to the respective label.

 -  Any medical or psychological condition, in the treating physician's opinion, which may
 hinder the patient from participating in this study for the expected 12 months

 -  Patients participating, in parallel, in an interventional clinical trial

 -  Patients participating, in parallel, in any other Novartis sponsored NIS generating
 primary data for an anti-VEGF drug