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Active, Not Recruiting

NCT Number: NCT05476926

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neovascular Age-related Macular Degeneration Branch Retinal Vein Occlusion Cardiovascular Diseases Central Retinal Vein Occlusion Diabetic Macular Edema Embolism and Thrombosis Eye Diseases Hemi-retinal Vein Occlusion Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Salud Ocular, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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)

Treatment and study plan

Faricimab

Drug

Faricimab will be administered as per local clinical practice and local labeling.

Other names: VABYSMO™, RO6867461, RG7716

Port Delivery System with Ranibizumab

Combination Product

The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.

Other names: SUSVIMO™, RG6321

Primary outcomes

  1. Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product

    Time frame: 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.

Secondary outcomes

  1. Change in Visual Acuity from Baseline Over Time, per Approved Retinal Indication and Product

    Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)

    Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

  2. Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product

    Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)

  3. Number of Treatments Over Time, per Approved Retinal Indication and Product

    Time frame: At 3, 6, and 12 months, and annually thereafter (up to 5 years)

  4. 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

    Time frame: From Baseline until end of study (up to 5 years)

  5. Percentage of Eyes with Treatment Switch by Reason for Switch Over Time, per Approved Retinal Indication and Product

    Time frame: At 3, 6, and 12 months, and annually thereafter (up to 5 years)

  6. 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

    Time frame: At 3, 6, and 12 months, and annually thereafter (up to 5 years)

  7. Total Number of Visits per Year, per Approved Retinal Indication and Product

    Time frame: Annually (up to 5 years)

  8. Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product

    Time frame: Annually (up to 5 years)

  9. Time Interval Between Treatments per Year, per Approved Retinal Indication and Product

    Time frame: Annually (up to 5 years)

  10. Number of Eyes Treated with Ocular Concomitant and Subsequent Medications by Type and Frequency During the Study, per Approved Retinal Indication and Product

    Time frame: From Baseline until end of study (up to 5 years)

  11. 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

    Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)

    Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

  12. Change in Visual Acuity from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product

    Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)

    Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

  13. Change in Visual Acuity from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product

    Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)

    Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

  14. Change in Visual Acuity from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product

    Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)

    Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

  15. Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product

    Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)

  16. Number of Participants with at Least One Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product

    Time frame: From Baseline until end of study (up to 5 years)

    Severity and seriousness will be independently assessed for each adverse event (AE). The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (e.g., rated as mild, moderate, or severe); the event itself may be of relatively minor medical significance.

  17. Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product

    Time frame: From Baseline until end of study (up to 5 years)

    Severity and seriousness will be independently assessed for each adverse event (AE). The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (e.g., rated as mild, moderate, or severe); the event itself may be of relatively minor medical significance.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)

Acronym: VOYAGER

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 27, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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