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

NCT05476926 · tracked via the Priya Life Science UK tracker

Sponsor

Hoffmann-La Roche

Phase

Observational

Started

2022-11-21

Last updated

2026-09-02

Condition(s) studied

Neovascular Age-related Macular DegenerationDiabetic Macular EdemaRetinal Vein OcclusionBranch Retinal Vein OcclusionCentral Retinal Vein OcclusionHemi-retinal Vein Occlusion

Investigational drug(s) / intervention(s)

FaricimabPort Delivery System with Ranibizumab

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

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

Trial sites (299)

Facility	City	Region
Retinal Research Institute, LLC	Phoenix	Arizona
California Eye Specialists Medical group Inc.	Pasadena	California
Retinal Consultants Medical Group	Sacramento	California
Advanced Research	Coral Springs	Florida
Retina Specialty Institute	Pensacola	Florida
University Retina and Macula Associates, PC	Lemont	Illinois
Springfield Clinic, Llp	Springfield	Illinois
Retina Associates of Kentucky	Lexington	Kentucky
Cumberland Valley Retina Consultants PC	Hagerstown	Maryland
Associated Retinal Consultants PC	Royal Oak	Michigan
Erie Retinal Surgery	Erie	Pennsylvania
Tennessee Retina PC	Nashville	Tennessee
Brown Retina Institute	San Antonio	Texas
Retina Center of Texas	Southlake	Texas
University of Utah, John Moran Eye Center	Salt Lake City	Utah
Piedmont Eye Center	Lynchburg	Virginia
Wagner Macula and Retina Center	Norfolk	Virginia
Spokane Eye Clinical Research	Spokane	Washington
Salud Ocular	Ciudad Autonoma de Buenos Aires	Buenos Aires
Instituto Oftalmologico de Buenos Aires S.A.	Buenos Aires	Argentina
Centro Oftalmologico Dr. Charles S.A.	Ciudad Autonoma Buenos Aires	Argentina
Centro Privado de Ojos Romagosa S.A	Córdoba	Argentina
CEO Centro de Especialidades Oftalmologicas Tucuman	San Miguel de Tucumán	Argentina
Retina and Macula Specialists	Hurstville	New South Wales
Sydney West Retina	Westmead	New South Wales
Sunshine Coast University Hospital	Geebung	Queensland
Centre For Eye Research Australia	East Melbourne	Victoria
Cabrini Hospital Malvern	Melbourne	Victoria
Retina Specialists Victoria	Rowville	Victoria
Lions Outback Vision Service in Broome	Broome	Western Australia
The Lions Eye Institute	Nedlands	Western Australia
Medical Center for Eye Health ? Focus Ltd	Sofia	Bulgaria
Specialized Eye Hospital Pentagram	Sofia	Bulgaria
Specialized Hospital for Active Treatment of Ophthalmologic Diseases ?Zora?, OOD	Sofia	Bulgaria
Eye Clinic St. Petka - Varna	Varna	Bulgaria
SHEDAT - Varna EOOD	Varna	Bulgaria
Retina Surgical Associates	New Westminster	British Columbia
Toronto Retina Institute	Don Mills	Ontario
St Joseph's Centre for Mountain Health Services	Hamilton	Ontario
St. Joseph's Health Care - London	London	Ontario

+ 259 more sites — see the full list on the official registry below.

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Other trials for the same condition

Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion Recruiting

Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA] Active, not recruiting

Extension Study for the Port Delivery System With Ranibizumab (Portal) Recruiting

A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration Active, not recruiting

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05476926 on ClinicalTrials.gov ↗ ← All trials in the UK