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Active Not Recruiting NCT05476926

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

Conditions: Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Hemi-retinal Vein Occlusion

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 6000
Sponsor: Hoffmann-La Roche

Location: Retinal Research Institute, LLC Phoenix Arizona

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.

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05476926). StuddyBuddy aggregates publicly available trial information.