Trials / Active Not Recruiting
Active Not RecruitingNCT05476926
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 6,000 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Neovascular Age-related Macular Degeneration
- Diabetic Macular Edema
- Retinal Vein Occlusion
- Branch Retinal Vein Occlusion
- Central Retinal Vein Occlusion
- Hemi-retinal Vein Occlusion
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Faricimab | Faricimab will be administered as per local clinical practice and local labeling. |
| COMBINATION_PRODUCT | Port Delivery System with Ranibizumab | The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling. |
Timeline
- Start date
- 2022-11-21
- Primary completion
- 2026-11-30
- Completion
- 2027-11-30
- First posted
- 2022-07-27
- Last updated
- 2026-03-16
Locations
299 sites across 29 countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Egypt, France, Germany, Hong Kong, Israel, Italy, Japan, Poland, Puerto Rico, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05476926. Inclusion in this directory is not an endorsement.