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

CRTH258A2402

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

2021-02-23

2023-06-28

2023-06-28

Completed

494

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 494, 'type': 'ACTUAL'}}

2023-07-27