RAZORBILL was 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 was 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 comprised a prospective data collection phase and a retrospective analysis of OCT images phase. The prospective observation period per patient was up to 12 months. The study included patients (naïve patients and patients who had 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.
Study Type
OBSERVATIONAL
Enrollment
494
There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled.
There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled.
There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled.
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment
An odds ratio of disease activity assessment from OCTs with and without enrichment was reported with a 95% confidence interval.
Time frame: 12 months
Degree of agreement in classification of disease activity using enriched and non-enriched OCT images
Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using OCT images
Time frame: 12 months
Difference in time needed for Disease Activity Assessment (DAA) between reviews with and without enrichment
the difference in time to DAA (time between begin of OCT viewing and result sub-mission) between cases reviewed with and without use of segmentation information was calculated.
Time frame: 12 months
Difference in confidence in DAA between reviews with and without enrichment
difference in confidence in DAA between cases reviewed with and without enrichment (rating of 1-10 per case, whereby a rating of 10 meant maximal confidence) was calculated
Time frame: 12 months
Acceptance of Discovery by physicians and whether it can optimize the ophthalmic clinical workflow
Physicians used a digital solution Discovery for managing imaging data and automatic segmentation of OCT volumes. To understand if such a tool is well suited for its role in its current form, holds value for physicians and can optimize clinical workflow, physicians were invited to complete questionnaires regarding their user experience.
Time frame: Month 12
Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment
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Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Ludwigsburg, Baden-Wurttemberg, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Düsseldorf, Germany
Novartis Investigative Site
Göttingen, Germany
Novartis Investigative Site
Münster, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Glasnevin, Dublin 9, Ireland
...and 7 more locations
Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment was provided
Time frame: Month 12
Central Subfield Thickness (CST) change
Course of Central Subfield Thickness (CST) change was provided
Time frame: 12 months
Best-corrected visual acuity change from baseline
Best-corrected visual acuity change from baseline was provided
Time frame: 12 months
Percentage of patients with ocular and non-ocular adverse events
Percentage of patients with ocular and non-ocular adverse events was provided
Time frame: 12 months
Subjective assessment of system correctness
Investigators assessed the correctness of the system on a scale from 0 to 10 (10 corresponds to maximum correctness) if segmentation algorithm was used.
Time frame: 12 months