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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 199 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Licensed anti-VEGFs
Patients being treated for nAMD with licensed anti-VEGFs
干预措施: brolucizumab (Drug)
Licensed anti-VEGFs
Patients being treated for nAMD with licensed anti-VEGFs
干预措施: ranibizumab (Drug)
Licensed anti-VEGFs
Patients being treated for nAMD with licensed anti-VEGFs
干预措施: aflibercept (Drug)
结局指标
主要结局
Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment
时间窗: 12 months
An odds ratio of disease activity assessment from OCTs with and without enrichment was reported with a 95% confidence interval.
Degree of agreement in classification of disease activity using enriched and non-enriched OCT images
时间窗: 12 months
Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using OCT images
次要结局
- Acceptance of Discovery by physicians and whether it can optimize the ophthalmic clinical workflow(Month 12)
- Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment(Month 12)
- Best-corrected visual acuity change from baseline(12 months)
- Difference in time needed for Disease Activity Assessment (DAA) between reviews with and without enrichment(12 months)
- Difference in confidence in DAA between reviews with and without enrichment(12 months)
- Subjective assessment of system correctness(12 months)
- Central Subfield Thickness (CST) change(12 months)
- Percentage of patients with ocular and non-ocular adverse events(12 months)