A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
- Neovascular Age-related Macular Degeneration
- Diabetic Macular Edema
Not yet recruiting
NCT05476926 MR41927
Trial 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 (Faricimab and Port Delivery System with Ranibizumab) in approved retinal indications (neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) 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. The study start in a country is contingent on the approval of at least one product.
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)
Eligibility Criteria
- Have provided informed consent, as required per local regulations
- Adult patients, as defined by local regulations and local product label, who are being treated with any approved Roche ophthalmology product in retinal indication in scope for this study, according to the investigator's discretion in routine clinical practice (irrespective of whether the patient is starting treatment at the time of enrollment or is already receiving treatment). Patients are also considered eligible if they are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication in scope for this study
- Concomitant participation 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 in scope for this study)
For the latest version of this information please go to www.forpatients.roche.com