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

Study Overview
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Brief Summary
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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

Detailed Description
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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 424 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 5 countries.

Official Title
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A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography (OCT) Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections

Conditions
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Neovascular Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: brolucizumab
* Drug: ranibizumab
* Drug: aflibercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 199 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Licensed anti-VEGFs<br>Patients being treated for nAMD with licensed anti-VEGFs | Drug: brolucizumab<br>* There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.<br>Drug: ranibizumab<br>* There is no treatment allocation. Patients administered Ranibizumab by prescription that have started before inclusion of the patient into the study will be enrolled.<br>Drug: aflibercept<br>* There is no treatment allocation. Patients administered Aflibercept by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odds ratio of disease activity identification from Optical Coherence Tomography (OCTs) with and without automatic augmentation | An odds ratio of disease activity identification from OCTs with and without automatic segmentation will be reported with a 95% confidence interval. | 12 months | 
| Degree of agreement in classification of disease activity using segmented OCT images | Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using segmented OCT images | 12 months | 
| Degree of agreement in classification of disease activity using non-segmented OCT images | Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using non-segmented OCT images | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess if Discovery is accepted by physicians and whether it can optimize the ophthalmic clinical workflow | Physicians will use 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 will be invited to complete questionnaires regarding their user experience. | Month 12 | 
| Percentage (%) of patients absent of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | Month 12 | 
| Estimate Central Subfield Thickness (CST) change and correlation with Visual Acuity (VA) | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | 12 months | 
| Visual Acuity (VA) change from baseline | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | Baseline, month 12 | 
| Percentage (%) of patients with ocular and non-ocular adverse events | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nAMD, Neovascular Age-Related Macular Degeneration, anti-VEGF, RAZORBILL, optical coherence tomography, OCT, Artificial Intelligence, Machine learning, Automatic OCT segmentation