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
- Conditions
- Neovascular Age-Related Macular Degeneration
- Interventions
- Registration Number
- NCT04662944
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 494
- Diagnosis of nAMD
- Male and Female patients with ≥18 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Licensed anti-VEGFs ranibizumab Patients being treated for nAMD with licensed anti-VEGFs Licensed anti-VEGFs aflibercept Patients being treated for nAMD with licensed anti-VEGFs Licensed anti-VEGFs brolucizumab Patients being treated for nAMD with licensed anti-VEGFs
- Primary Outcome Measures
Name Time Method Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment 12 months An odds ratio of disease activity assessment from OCTs with and without enrichment was reported with a 95% confidence interval.
Degree of agreement in classification of disease activity using enriched and non-enriched OCT images 12 months Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using OCT images
- Secondary Outcome Measures
Name Time Method Acceptance of Discovery by physicians and whether it can optimize the ophthalmic clinical workflow Month 12 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.
Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment Month 12 Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment was provided
Best-corrected visual acuity change from baseline 12 months Best-corrected visual acuity change from baseline was provided
Difference in time needed for Disease Activity Assessment (DAA) between reviews with and without enrichment 12 months 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.
Difference in confidence in DAA between reviews with and without enrichment 12 months 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
Subjective assessment of system correctness 12 months Investigators assessed the correctness of the system on a scale from 0 to 10 (10 corresponds to maximum correctness) if segmentation algorithm was used.
Central Subfield Thickness (CST) change 12 months Course of Central Subfield Thickness (CST) change was provided
Percentage of patients with ocular and non-ocular adverse events 12 months Percentage of patients with ocular and non-ocular adverse events was provided
Trial Locations
- Locations (1)
Novartis Investigative Site
🇪🇸Leon, Spain