RAZORBILL: 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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04662944

Collaborator

(none)

424

Enrollment

Locations

28.2

Anticipated Duration (Months)

24.9

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neovascular Age-Related Macular Degeneration	Drug: brolucizumab Drug: ranibizumab Drug: aflibercept

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

424 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Feb 23, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Licensed anti-VEGFs Patients being treated for nAMD with licensed anti-VEGFs	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.

Arm

Intervention/Treatment

Licensed anti-VEGFs

Patients being treated for nAMD with licensed anti-VEGFs

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 199 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Hamilton	Ontario	Canada	L8G 5E4
2	Novartis Investigative Site	Toronto	Ontario	Canada	M8X 2X3
3	Novartis Investigative Site	Montreal	Quebec	Canada	H1V 1G5
4	Novartis Investigative Site	Ludwigsburg	Baden-Wuerttemberg	Germany	71638
5	Novartis Investigative Site	Bonn		Germany	53105
6	Novartis Investigative Site	Duesseldorf		Germany	40212
7	Novartis Investigative Site	Gottingen		Germany	37075
8	Novartis Investigative Site	Muenster		Germany	48145
9	Novartis Investigative Site	Ulm		Germany	89075
10	Novartis Investigative Site	Glasnevin	Dublin 9	Ireland	D09 YN97
11	Novartis Investigative Site	Waterford		Ireland
12	Novartis Investigative Site	Milano	MI	Italy	20132
13	Novartis Investigative Site	Milano	MI	Italy	20157
14	Novartis Investigative Site	Barcelona	Catalunya	Spain	08035
15	Novartis Investigative Site	Barcelona	Catalunya	Spain	08036
16	Novartis Investigative Site	Bormujos	Sevilla	Spain	41930
17	Novartis Investigative Site	Leon		Spain	24080