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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT05476926
Status
Active Not Recruiting

Conditions

  • Branch Retinal Vein Occlusion
  • Central Retinal Vein Occlusion
  • Diabetic Macular Edema
  • Hemi-retinal Vein Occlusion
  • Neovascular Age-related Macular Degeneration
  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Faricimab — DRUG
    Faricimab will be administered as per local clinical practice and local labeling.
  • Port Delivery System with Ranibizumab — COMBINATION_PRODUCT
    The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.

Study Details

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.

Key Dates

First listed
Jul 27, 2022
Start date
Nov 21, 2022
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
6,000 participants (estimated)

Arms

  • Arm: Cohort 1: Faricimab for nAMD
  • Arm: Cohort 2: Faricimab for DME
  • Arm: Cohort 3: Port Delivery System with Ranibizumab for nAMD
  • Arm: Cohort 4: Faricimab for BRVO
  • Arm: Cohort 5: Faricimab for CRVO/HRVO

Primary Outcome Measure

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

Locations (18)

FacilityCityStateZIPSite coordinators
Retinal Research Institute, LLCPhoenixArizona85014-
California Eye Specialists Medical group Inc.PasadenaCalifornia91107-
Retinal Consultants Medical GroupSacramentoCalifornia95825-
Advanced ResearchCoral SpringsFlorida33067-
Retina Specialty InstitutePensacolaFlorida32503-
University Retina and Macula Associates, PCLemontIllinois60439-
Springfield Clinic, LlpSpringfieldIllinois62703-
Retina Associates of KentuckyLexingtonKentucky40509-
Cumberland Valley Retina Consultants PCHagerstownMaryland21740-
Associated Retinal Consultants PCRoyal OakMichigan48073-
Erie Retinal SurgeryEriePennsylvania16507-
Tennessee Retina PCNashvilleTennessee37203-
Brown Retina InstituteSan AntonioTexas78251-4551-
Retina Center of TexasSouthlakeTexas76092-1352-
University of Utah, John Moran Eye CenterSalt Lake CityUtah84132-
Piedmont Eye CenterLynchburgVirginia24502-
Wagner Macula and Retina CenterNorfolkVirginia23502-3933-
Spokane Eye Clinical ResearchSpokaneWashington99204-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retinal Research Institute, LLC· Phoenix, AZCalifornia Eye Specialists Medical group Inc.· Pasadena, CARetinal Consultants Medical Group· Sacramento, CAAdvanced Research· Coral Springs, FLRetina Specialty Institute· Pensacola, FLUniversity Retina and Macula Associates, PC· Lemont, IL

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