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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Faricimab; Combination product: Port Delivery System with Ranibizumab

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: MR41927 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Australia
  • New South Wales
    • Hurstville, New South Wales, Australia, 2220
      • Recruiting
      • Retina and Macula Specialists
  • Queensland
    • Geebung, Queensland, Australia, 4034
      • Recruiting
      • Sunshine Coast University Hospital
  • Western Australia
    • Broome, Western Australia, Australia, 6725
      • Recruiting
      • Lions Outback Vision Service in Broome
• Bulgaria
  • Sofia, Bulgaria, 1319
    • Recruiting
    • Specialized Eye Hospital Pentagram
• Canada
  • Quebec, Canada, G1V 1T6
    • Recruiting
    • Centre Oculaire de Quebec
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 5H1
      • Recruiting
      • Retina Surgical Associates
  • Ontario
    • Hamilton, Ontario, Canada, L9C 0E3
      • Recruiting
      • St Joseph's Centre for Mountain Health Services
    • London, Ontario, Canada, N6A 4V2
      • Recruiting
      • St. Joseph's Health Care - London
    • Ottawa, Ontario, Canada, K2B 7E9
      • Recruiting
      • The Retina Centre of Ottawa
    • Toronto, Ontario, Canada, M3C 0G9
      • Recruiting
      • Toronto Retina Institute
    • Vaughan, Ontario, Canada, L4K 0J4
      • Recruiting
      • Clarity eye Institute
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 0E8
      • Recruiting
      • Institut de l'Oeil des Laurentides
    • Montreal, Quebec, Canada
      • Recruiting
      • Eye Health MD (Opthalmology)
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR) - Centre Ambulatoire
    • Sainte-catherine, Quebec, Canada, J5C 1V9
      • Recruiting
      • Retina MD Clinic
• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • Special Hospital for Ophthalmology Svjetlost
• France
  • Bordeaux, France, 33000
    • Recruiting
    • Centre Rétine Gallien
  • Dijon Cedex, France
    • Recruiting
    • Chu Dijon - Hôpital François Mitterrand
  • La Rochelle cedex, France, 17019
    • Recruiting
    • Hôpital Saint-Louis - La Rochelle
  • Lyon, France, 69003
    • Recruiting
    • Hopital d'Instruction des Armées Desgenettes
  • Montargis, France, 45200
    • Recruiting
    • Clinique de Montargis
  • Montauban, France, 82000
    • Recruiting
    • Clinique Honore Cave
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes - Hôtel Dieu
  • Paris, France, 75015
    • Recruiting
    • Centre Ophtalmologique d?Imagerie et de Laser
• Germany
  • Berlin, Germany, 10713
    • Recruiting
    • St. Gertrauden Krankenhaus Berlin, Augenheilkunde
  • Berlin, Germany, 13353
    • Recruiting
    • Charité Universitätsmedizin Berlin; Hämatologie/Onkologie und Tumorimmunologie
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz gGmbH
  • Frankfurt, Germany, 60590
    • Recruiting
    • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Greifswald, Germany, 17475
    • Recruiting
    • Universitaetsmedizin Greifswald
  • Hannover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitaetsklinikum Heidelberg
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitaetsklinikum Leipzig
  • Ludwigshafen, Germany, 67063
    • Recruiting
    • Apotheke am Klinikum Ludwigshafen
  • Magdeburg, Germany, 39120
    • Recruiting
    • Universitaetsklinikum Magdeburg A.oe.R; Division of Cardiology
  • Mannheim, Germany, 68305
    • Recruiting
    • Universitätsklinikum Mannheim
  • Rostock, Germany, 18057
    • Recruiting
    • Universitaetsaugenklinik Rostock
• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Recruiting
      • Azienda Ospedaliero Universitaria Mater Domini
  • Lazio
    • Roma, Lazio, Italy, 189
      • Recruiting
      • Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Recruiting
      • IRCCS Ospedale Policlinico San Martino
  • Piemonte
    • Acquaviva Delle Fonti, Piemonte, Italy, 70021
      • Recruiting
      • Ente Ecclesiastico Ospedale Generale Regionale F Miulli
    • Torino, Piemonte, Italy, 10128
      • Recruiting
      • Ospedale Mauriziano Umberto I; Divisione Onco-Ematologia
  • Sardegna
    • Sassuolo, Sardegna, Italy, 41049
      • Recruiting
      • Ospedale Di Sassuolo
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
      • Recruiting
      • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
• Japan
  • Aichi, Japan, 467-8602
    • Recruiting
    • Nagoya City University Hospital
  • Aichi, Japan, 457-8510
    • Recruiting
    • Chukyo Hospital
  • Aichi, Japan, 480-1195
    • Recruiting
    • Aichi Medical University Hospital
  • Chiba, Japan, 260-8677
    • Recruiting
    • Chiba University Hospital
  • Chiba, Japan, 285-8741
    • Recruiting
    • Toho University Sakura Medical Center
  • Chiba, Japan, 279-0021
    • Recruiting
    • Juntendo University Urayasu Hospital
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
  • Fukuoka, Japan, 830-0011
    • Recruiting
    • Kurume University Hospital
  • Gifu, Japan, 501-1194
    • Recruiting
    • Gifu University Hospital
  • Hiroshima, Japan, 734-8551
    • Recruiting
    • Hiroshima University Hospital
  • Hokkaido, Japan, 060-8648
    • Recruiting
    • Hokkaido University Hospital
  • Hokkaido, Japan, 060-8604
    • Recruiting
    • Sapporo City General Hospital
  • Hyogo, Japan, 650-0017
    • Recruiting
    • Kobe University Hospital
  • Ibaraki, Japan, 305-8576
    • Recruiting
    • University of tsukuba hospital
  • Ibaraki, Japan, 310-0845
    • Recruiting
    • Kozawa Eye Hospital and Diabetes Center
  • Kagawa, Japan, 761-0793
    • Recruiting
    • Kagawa University Hospital
  • Kanagawa, Japan, 232-0024
    • Recruiting
    • Yokohama City University Medical Center
  • Meguro-ku, Japan, 152-8902
    • Recruiting
    • NHO Tokyo Medical Center
  • Mie, Japan, 514-8507
    • Recruiting
    • Mie University Hospital
  • Nagasaki, Japan, 852-8501
    • Recruiting
    • Nagasaki University Hospital
  • Nagasaki, Japan, 852-8511
    • Recruiting
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Osaka, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Saitama, Japan, 350-0451
    • Recruiting
    • Saitama Medical University Hospital
  • Shiga, Japan, 520-2192
    • Recruiting
    • Shiga University Of Medical Science Hospital
  • Takatsuki-shi, Japan, 569-8686
    • Recruiting
    • Osaka Medical and Pharmaceutical University Hospital
  • Tokushima, Japan, 770-8503
    • Recruiting
    • Tokushima University Hospital
  • Tokyo, Japan, 162-8666
    • Recruiting
    • Tokyo Women's Medical University Hospital
  • Yamaguchi, Japan, 755-8505
    • Recruiting
    • Yamaguchi University Hospital
  • Yoshida-gun, Japan, 910-1193
    • Recruiting
    • University of Fukui Hospital
• Puerto Rico
  • Arecibo, Puerto Rico, 00612
    • Active, not recruiting
    • Emanuelli Research and Development Center
• Singapore
  • Singapore, Singapore, 248649
    • Recruiting
    • Eye & Retina Surgeons
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital; Ophthalmology Department
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital; CTRU/OCS, Research
  • Singapore, Singapore, 169608
    • Recruiting
    • Singapore National Eye Centre
  • Singapore, Singapore, 329563
    • Recruiting
    • Eagle Eye Centre
• Spain
  • Burgos, Spain, 09005
    • Recruiting
    • Complejo Asistencial Universitario de Burgos
  • Valladolid, Spain, 47012
    • Recruiting
    • Hospital Universitario Rio Hortega
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Recruiting
      • Hospital De Basurto
• Switzerland
  • Aarau, Switzerland, 5001
    • Recruiting
    • Kantonsspital Aarau AG
  • Binningen, Switzerland, 4102
    • Recruiting
    • Vista Augenklinik Binningen
  • Lausanne, Switzerland, 1004
    • Recruiting
    • Hôpital ophtalmique Jules-Gonin
  • Lausanne, Switzerland, 1006
    • Recruiting
    • Swiss Visio Montchoisi
  • Lugano, Switzerland, 6900
    • Recruiting
    • Ospedale Regionale di Lugano
  • Luzern, Switzerland, 6004
    • Recruiting
    • Luzerner Kantonsspital Luzern
  • Zürich, Switzerland, 8055
    • Recruiting
    • Stadtspital Triemli
• United Arab Emirates
  • Abu dhabi, United Arab Emirates, 7400
    • Recruiting
    • Burjeel Hopital
  • Dubai, United Arab Emirates, 251533
    • Recruiting
    • Medcare Eye Center - Dubai
• United Kingdom
  • Bedford, United Kingdom, MK429DJ
    • Recruiting
    • Bedford Hospital
  • Belfast, United Kingdom, BT14 6AB
    • Recruiting
    • Mater Infirmorum Hospital
  • Bradford, United Kingdom, BD9 6RJ
    • Recruiting
    • Bradford Royal Infirmary
  • Bristol, United Kingdom, BS1 2LX
    • Recruiting
    • Bristol Eye Hospital
  • Cardiff, United Kingdom, CF14 4XW
    • Recruiting
    • University Hospital of Wales
  • Cheltenham, United Kingdom, GL53 7AN
    • Recruiting
    • Cheltenham General Hospital
  • Coventry, United Kingdom, CV2 2DX
    • Recruiting
    • University Hospitals Coventry and Warwickshire NHS Trust
  • Frimley, United Kingdom, GU16 7UJ
    • Recruiting
    • Frimley Park Hospital
  • Harrow, United Kingdom, HA1 3UJ
    • Recruiting
    • North West London Hospitals NHS Trust
  • Hull, United Kingdom, HU3 2JZ
    • Recruiting
    • Hull Royal Infirmary
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St James University Hospital
  • Liverpool, United Kingdom, L7 8YE
    • Recruiting
    • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
  • London, United Kingdom, EC1V 2PD
    • Recruiting
    • Moorfields Eye Hospital; Clinical Trials Pharmacy Department
  • Maidstone, Kent, United Kingdom, ME16 9QQ
    • Recruiting
    • Maidstone Hospital; Eye Unit
  • Manchester, United Kingdom, M13 9WL
    • Recruiting
    • Manchester Royal Eye Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Recruiting
    • Royal Victoria Infirmary
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • John Radcliffe Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Recruiting
    • Royal Hallamshire Hospital
  • Sunderland, United Kingdom, SR2 9HP
    • Recruiting
    • Sunderland Eye Infirmary
  • Torquay, United Kingdom, TQ2 7AA
    • Recruiting
    • Torbay Hospital; Oncology
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Recruiting
      • Retinal Research Institute, LLC
  • California
    • Beverly Hills, California, United States, 90211
      • Recruiting
      • Retina-Vitreous Associates Medical Group
    • Pasadena, California, United States, 91107
      • Recruiting
      • California Eye Specialists Medical group Inc.
    • Sacramento, California, United States, 95825
      • Recruiting
      • Retinal Consultants Medical Group
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Recruiting
      • Advanced Research
    • Pensacola, Florida, United States, 32503
      • Recruiting
      • Retina Specialty Institute
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • Recruiting
      • University Retina and Macula Associates, PC
    • Springfield, Illinois, United States, 62703
      • Recruiting
      • Springfield Clinic, Llp
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Recruiting
      • Retina Associates of Kentucky
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Recruiting
      • Cumberland Valley Retina Consultants PC
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Associated Retinal Consultants PC
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Recruiting
      • Erie Retinal Surgery
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Recruiting
      • Palmetto Retina Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Retina PC
  • Texas
    • San Antonio, Texas, United States, 78251-4551
      • Recruiting
      • Brown Retina Institute
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah, John Moran Eye Center
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Recruiting
      • Piedmont Eye Center
    • Norfolk, Virginia, United States, 23502-3933
      • Recruiting
      • Wagner Macula and Retina Center
  • Washington
    • Spokane, Washington, United States, 99204
      • Recruiting
      • Spokane Eye Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients being treated with specified Roche ophthalmology products approved in retinal indications in real-world, routine clinical practice.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Faricimab for nAMD	Drug: Faricimab; Faricimab will be administered as per local clinical practice and local labeling.; Other Names: VABYSMO™; RO6867461; RG7716
Faricimab for DME	Drug: Faricimab; Faricimab will be administered as per local clinical practice and local labeling.; Other Names: VABYSMO™; RO6867461; RG7716
Port Delivery System with Ranibizumab for nAMD	Combination product: Port Delivery System with Ranibizumab; The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.; Other Names: SUSVIMO™; RG6321

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.	Baseline and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product		Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
Number of Treatments per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
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		From Baseline until end of study (up to 5 years)
Percentage of Eyes with Treatment Switch by Reason for Switch Over Time, per Approved Retinal Indication and Product		At 3 and 6 months, and 1, 2, 3, 4, and 5 years
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		At 3 and 6 months, and 1, 2, 3, 4, and 5 years
Total Number of Visits per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
Time Interval Between Treatments per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
Number of Eyes Treated with Ocular Concomitant and Subsequent Medications by Type and Frequency During the Study, per Approved Retinal Indication and Product		From Baseline until end of study (up to 5 years)
Number of Participants with at Least One Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product	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.	From Baseline until end of study (up to 5 years)
Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product	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.	From Baseline until end of study (up to 5 years)
Change in Visual Acuity from Baseline Over Time, per Approved Retinal Indication and Product	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.	Baseline, 3 and 6 months, and 2, 3, 4, and 5 years
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	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.	Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
Change in Visual Acuity from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.	Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
Change in Visual Acuity from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.	Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
Change in Visual Acuity from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.	Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product		Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Faricimab
• Other Study ID Numbers: MR41927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes