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

ClinicalTrials.gov Identifier: NCT04662944

Novartis Reference Number: CRTH258A2402

Last Update: May 18, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Neovascular Age-Related Macular Degeneration
Phase 
Not Given
Overall status 
Recruiting
Start date 
Feb 23, 2021
Completion date 
Jun 30, 2023
Gender 
All
Age(s)
18 Years - 199 Years (Adult, Older Adult)

Interventions

Drug
brolucizumab
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Drug
ranibizumab
There is no treatment allocation. Patients administered Ranibizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Drug
aflibercept
There is no treatment allocation. Patients administered Aflibercept by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Diagnosis of nAMD
Male and Female patients with ≥40 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

Study Locations

Canada
Novartis Investigative Site
Recruiting
Hamilton, L8G 5E4
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M8X 2X3
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H1V 1G5
Quebec
Canada
Germany
Novartis Investigative Site
Recruiting
Ludwigsburg, 71638
Baden-Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Duesseldorf, 40212
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48145
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89075
-
Germany
Ireland
Novartis Investigative Site
Recruiting
Glasnevin, D09 YN97
Dublin 9
Ireland
Novartis Investigative Site
Recruiting
Waterford,
-
Ireland
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20157
MI
Italy
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Bormujos, 41930
Sevilla
Spain
Novartis Investigative Site
Recruiting
Leon, 24080
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]