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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-23

Study Completion Date

2023-06-28

Brief Summary

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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

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Detailed Description

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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

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Neovascular Age-Related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Licensed anti-VEGFs

Patients being treated for nAMD with licensed anti-VEGFs

brolucizumab

Intervention Type DRUG

There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled.

ranibizumab

Intervention Type DRUG

There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled.

aflibercept

Intervention Type DRUG

There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled.

Interventions

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brolucizumab

There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled.

Intervention Type DRUG

ranibizumab

There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled.

Intervention Type DRUG

aflibercept

There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

199 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No