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Not recruiting

Observational Study

Sponsor:

Hoffmann-La Roche

Code:

NCT05476926

Conditions

Neovascular Age-related Macular Degeneration

Diabetic Macular Edema

Retinal Vein Occlusion

Branch Retinal Vein Occlusion

Central Retinal Vein Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Faricimab

Port Delivery System with Ranibizumab

Study Details

Brief 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

Study ID

NCT05476926

Start date

Nov 21, 2022

Status verified date

Nov, 2025

Completion date

Sep 13, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

6000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1: Faricimab for nAMD

Cohort 2: Faricimab for DME

Cohort 3: Port Delivery System with Ranibizumab for nAMD

Cohort 4: Faricimab for BRVO

Cohort 5: Faricimab for CRVO/HRVO

Interventions

Faricimab

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

Port Delivery System with Ranibizumab

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

Primary outcome measure

  • Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product [ Time Frame: Baseline and 1 year ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: MR41927 https://forpatients.roche.com/

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Retinal Consultants Medical Group

Recruiting

Sacramento, California, United States, 95825

Springfield Clinic, Llp

Recruiting

Springfield, Illinois, United States, 62703

Erie Retinal Surgery

Recruiting

Erie, Pennsylvania, United States, 16507

University of Utah, John Moran Eye Center

Recruiting

Salt Lake City, Utah, United States, 84132

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502

St. Joseph's Health Care - London

Recruiting

London, Ontario, Canada, N6A 4V2

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2025-11-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.