NCT05476926进行中（未招募）不适用
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6,000
- 试验地点
- 299
- 主要终点
- Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product
研究概览
简要总结
The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products in approved retinal indications (Faricimab for neovascular age-related macular degeneration [nAMD], diabetic macular edema [DME], and retinal vein occlusion; Port Delivery System with Ranibizumab for nAMD) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Have provided informed consent, as required per local regulations 2.a) Adult patient, as defined by local regulations and local product label, who is newly initiating treatment (or initiated treatment in the previous visit) with a specified approved Roche ophthalmology product in retinal indication of interest for this study in at least one eye, according to the investigator's discretion in routine clinical practice; OR 2.b) Adult patient, as defined by local regulations and local product label, who is continuing treatment with any specified approved Roche ophthalmology product in retinal indication of interest for this study in at least one eye after initiating that treatment in a Roche interventional trial.
排除标准
- •1. Concomitant participation of the patient in an investigational ophthalmology clinical trial that includes receipt of any investigational drug or procedure within the last 28 days prior to enrollment (this restriction does not apply to patients who are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication of interest for this study)
研究组 & 干预措施
Cohort 3: Port Delivery System with Ranibizumab for nAMD
干预措施: Port Delivery System with Ranibizumab (Combination Product)
Cohort 1: Faricimab for nAMD
干预措施: Faricimab (Drug)
Cohort 4: Faricimab for BRVO
干预措施: Faricimab (Drug)
Cohort 2: Faricimab for DME
干预措施: Faricimab (Drug)
Cohort 5: Faricimab for CRVO/HRVO
干预措施: Faricimab (Drug)
结局指标
主要结局
Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product
时间窗: Baseline and 1 year
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
次要结局
- Change in Visual Acuity from Baseline Over Time, per Approved Retinal Indication and Product(Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product(Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Number of Treatments Over Time, per Approved Retinal Indication and Product(At 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Cumulative Time Spent on Each Treatment per Eye, Overall and per Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other), per Approved Retinal Indication and Product(From Baseline until end of study (up to 5 years))
- Percentage of Eyes with Treatment Switch by Reason for Switch Over Time, per Approved Retinal Indication and Product(At 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time, per Approved Retinal Indication and Product(At 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Total Number of Visits per Year, per Approved Retinal Indication and Product(Annually (up to 5 years))
- Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product(Annually (up to 5 years))
- Time Interval Between Treatments per Year, per Approved Retinal Indication and Product(Annually (up to 5 years))
- Number of Eyes Treated with Ocular Concomitant and Subsequent Medications by Type and Frequency During the Study, per Approved Retinal Indication and Product(From Baseline until end of study (up to 5 years))
- Change in Visual Acuity from Baseline Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other), per Approved Retinal Indication and Product(Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Change in Visual Acuity from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product(Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Change in Visual Acuity from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product(Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Change in Visual Acuity from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product(Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product(Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years))
- Number of Participants with at Least One Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product(From Baseline until end of study (up to 5 years))
- Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product(From Baseline until end of study (up to 5 years))
研究者
研究点 (299)
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