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

Diabetic Macular Edema Clinical Trial

— VOYAGER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476926
• Other study ID #: MR41927
• Status: Recruiting
• Start date: November 21, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: MR41927 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration

Intervention

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

Combination Product:
• Port Delivery System with Ranibizumab
The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.

Locations

Country	Name	City	State
Australia	Lions Outback Vision Service in Broome	Broome	Western Australia
Australia	Sunshine Coast University Hospital	Geebung	Queensland
Australia	Retina and Macula Specialists	Hurstville	New South Wales
Australia	Cabrini Hospital Malvern	Malvern	Victoria
Bulgaria	Medical Center for Eye Health ? Focus Ltd	Sofia
Bulgaria	Specialized Eye Hospital Pentagram	Sofia
Bulgaria	Eye Clinic St. Petka - Varna	Varna
Bulgaria	SHEDAT - Varna EOOD	Varna
Canada	Institut De L'Oeil Des Laurentides	Boisbriand	Quebec
Canada	St Joseph's Centre for Mountain Health Services	Hamilton	Ontario
Canada	St. Joseph's Health Care - London	London	Ontario
Canada	Eye Health MD (Opthalmology)	Montreal	Quebec
Canada	Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR) - Centre Ambulatoire	Montreal	Quebec
Canada	Retina Surgical Associates	New Westminster	British Columbia
Canada	The Retina Centre of Ottawa	Ottawa	Ontario
Canada	Centre Oculaire de Quebec	Quebec
Canada	Retina MD Clinic	Sainte-catherine	Quebec
Canada	Toronto Retina Institute	Toronto	Ontario
Canada	Clarity eye Institute	Vaughan	Ontario
Chile	Centro de la Vision	Las Condes
Chile	Fundacion Oftalmologica Los Andes	Vitacura
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	Special Hospital for Ophthalmology Svjetlost	Zagreb
Czechia	Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha	Praha 6
France	Centre Rétine Gallien	Bordeaux
France	Clinique des Yeux Bordeaux	Bordeaux Floirac
France	Centre Hospitalier Intercommunal de Créteil	Creteil cedex
France	CHU Dijon - Hopital Francois Mitterrand	Dijon Cedex
France	Clinique du Val d'Ouest- Institut Rhône Alpin	Ecully
France	Hôpital Saint-Louis - La Rochelle	La Rochelle cedex
France	Centre Hospitalier de Versailles	Le Chesnay Cedex
France	Hopital Saint Vincent de Paul - GHICL Lille - Parent	Lille
France	Centre Ophtalmologique Rabelais	Lyon
France	Hopital d'Instruction des Armées Desgenettes	Lyon
France	Hôpital Nord - CHU Marseille#	Marseille
France	Clinique de Montargis	Montargis
France	Clinique Honore Cave	Montauban
France	Centre Des Arceaux	Montpellier
France	CHU de Nantes - Hotel Dieu	Nantes
France	Clinique Sourdille	Nantes cedex 1
France	CHU Nice - Hôpital Saint Roch	Nice
France	Centre Ophtalmologique d?Imagerie et de Laser	Paris
France	CHU de St-Etienne - Hopital Nord	Saint Etienne
France	Centre St Exupery	St Cyr Sur Loire
France	Institut Sourdille	St Herblain
France	Hopital Purpan	Toulouse
Germany	Charité Universitätsmedizin Berlin; Hämatologie/Onkologie und Tumorimmunologie	Berlin
Germany	St. Gertrauden Krankenhaus Berlin, Augenheilkunde	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt
Germany	Universitaetsmedizin Greifswald	Greifswald
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Apotheke am Klinikum Ludwigshafen	Ludwigshafen
Germany	Universitaetsklinikum Magdeburg A.oe.R; Division of Cardiology	Magdeburg
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Universitaetsaugenklinik Rostock	Rostock
Israel	Rambam Health Care Campus; Cardiology Dept.	Haifa
Israel	Hadassah	Jerusalem
Italy	Ente Ecclesiastico Ospedale Generale Regionale F Miulli	Acquaviva Delle Fonti	Piemonte
Italy	Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Gaspare Rodolico)	Catania	Sicilia
Italy	Azienda Ospedaliero Universitaria Mater Domini	Catanzaro	Calabria
Italy	IRCCS Ospedale Policlinico San Martino	Genova	Liguria
Italy	Ospedale San Raffaele; Clinica Medica I	Milano	Lombardia
Italy	Ospedale Monaldi - AORN dei Colli; U.O.C. Oculistica	Napoli	Campania
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Sicilia
Italy	Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien	Roma	Lazio
Italy	Ospedale Di Sassuolo	Sassuolo	Sardegna
Italy	Città della Salute e della Scienza di Torino. Presidio Molinette	Torino	Piemonte
Italy	Ospedale Mauriziano Umberto I; Divisione Onco-Ematologia	Torino	Piemonte
Italy	Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia	Udine	Friuli-Venezia Giulia
Italy	Azienda Ospedaliera Desio	Vimercate	Lombardia
Japan	Aichi Medical University Hospital	Aichi
Japan	Chukyo Hospital	Aichi
Japan	Nagoya City University Hospital	Aichi
Japan	Chiba University Hospital	Chiba
Japan	Juntendo University Urayasu Hospital	Chiba
Japan	Toho University Sakura Medical Center	Chiba
Japan	University of Yamanashi Hospital	Chuo-shi
Japan	Kurume University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Gifu University Hospital	Gifu
Japan	Hiroshima University Hospital	Hiroshima
Japan	Hokkaido University Hospital	Hokkaido
Japan	Sapporo City General Hospital	Hokkaido
Japan	Kobe University Hospital	Hyogo
Japan	Kozawa eye hospital and diabetes center	Ibaraki
Japan	University of Tsukuba Hospital	Ibaraki
Japan	Kagawa University Hospital	Kagawa
Japan	Yokohama City University Medical Center	Kanagawa
Japan	NHO Tokyo Medical Center	Meguro-ku
Japan	Mie University Hospital	Mie
Japan	Shinshu University Hospital	Nagano
Japan	Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki
Japan	Nagasaki University Hospital	Nagasaki
Japan	Kansai Medical University Hospital	Osaka
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Tazuke-kofukai Medical Research Institute Kitano Hospital	Osaka-shi
Japan	Saitama Medical University Hospital	Saitama
Japan	Shiga University Of Medical Science Hospital	Shiga
Japan	Osaka University Hospital	Suita
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki-shi
Japan	Tokushima University Hospital	Tokushima
Japan	Tokyo Women's Medical University Hospital	Tokyo
Japan	Yamaguchi University Hospital	Yamaguchi
Japan	University of Fukui Hospital	Yoshida-gun
Puerto Rico	Emanuelli Research and Development Center	Arecibo
Singapore	Eagle Eye Centre	Singapore
Singapore	Eye & Retina Surgeons	Singapore
Singapore	National University Hospital; Ophthalmology Department	Singapore
Singapore	Singapore National Eye Centre	Singapore
Singapore	Tan Tock Seng Hospital; CTRU/OCS, Research	Singapore
Spain	Hospital Universitario Principe de Asturias	Alcala de Henares	Madrid
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Dos de Maig	Barcelona
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Complejo Asistencial Universitario de Burgos	Burgos
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Universitario Virgen de La Arrixaca	Murcia
Spain	Complejo Hospitalario Universitario de Santiago.	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario Rio Hortega	Valladolid
Switzerland	Kantonsspital Aarau AG	Aarau
Switzerland	Inselspital-Universitaetsspital Bern	Bern
Switzerland	Vista Augenklinik Binningen	Binningen
Switzerland	Hôpital ophtalmique Jules-Gonin	Lausanne
Switzerland	Swiss Visio Montchoisi	Lausanne
Switzerland	Ospedale Regionale di Lugano	Lugano
Switzerland	Luzerner Kantonsspital Luzern	Luzern
Switzerland	Stadtspital Triemli	Zürich
United Arab Emirates	Burjeel Hopital	Abu dhabi
United Arab Emirates	Medcare Eye Center - Dubai	Dubai
United Kingdom	Bedford Hospital	Bedford
United Kingdom	Mater Infirmorum Hospital	Belfast
United Kingdom	Birmingham Midland Eye Centre	Birmingham
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	Essex County Hospital	Colchester
United Kingdom	University Hospitals Coventry and Warwickshire NHS Trust	Coventry
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	North West London Hospitals NHS Trust	Harrow
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	St James University Hospital	Leeds
United Kingdom	Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre	Liverpool
United Kingdom	Moorfields Eye Hospital; Clinical Trials Pharmacy Department	London
United Kingdom	Maidstone Hospital; Eye Unit	Maidstone, Kent
United Kingdom	Manchester Royal Eye Hospital	Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	James Paget University Hospitals NHS Foundation Trust	Norfolk
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Sunderland Eye Infirmary	Sunderland
United Kingdom	Torbay Hospital; Oncology	Torquay
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Advanced Research	Deerfield Beach	Florida
United States	Erie Retinal Surgery	Erie	Pennsylvania
United States	Cumberland Valley Retina Consultants PC	Hagerstown	Maryland
United States	Retina Associates of Kentucky	Lexington	Kentucky
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Tennessee Retina PC	Nashville	Tennessee
United States	Wagner Macula and Retina Center	Norfolk	Virginia
United States	University Retina and Macula Associates, PC	Oak Forest	Illinois
United States	California Eye Specialists Medical group Inc.	Pasadena	California
United States	Retina Specialty Institute	Pensacola	Florida
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Associated Retinal Consultants PC	Royal Oak	Michigan
United States	Retinal Consultants Medical Group	Sacramento	California
United States	University of Utah, John Moran Eye Center	Salt Lake City	Utah
United States	Brown Retina Institute	San Antonio	Texas
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Springfield Clinic, Llp	Springfield	Illinois
United States	Palmetto Retina Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  France,  Germany,  Israel,  Italy,  Japan,  Puerto Rico,  Singapore,  Spain,  Switzerland,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Treatments per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
Secondary	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)
Secondary	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
Secondary	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
Secondary	Total Number of Visits per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
Secondary	Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
Secondary	Time Interval Between Treatments per Year, per Approved Retinal Indication and Product		1, 2, 3, 4, and 5 years
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)