NCT04662944

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 (OCT) Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 494 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 199 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	brolucizumab	There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled.
DRUG	ranibizumab	There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled.
DRUG	aflibercept	There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled.

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2020-12-10
• Last updated: 2024-06-18

Locations

17 sites across 5 countries: Canada, Germany, Ireland, Italy, Spain