A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Imag… (NCT04662944) | Clinical Trial Compass
CompletedNot Applicable
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
Canada, Germany494 participantsStarted 2021-02-23
Plain-language 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
Who can participate
Age range18 Years – 199 Years
SexALL
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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 tr…
What they're measuring
1
Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment
Timeframe: 12 months
2
Degree of agreement in classification of disease activity using enriched and non-enriched OCT images