Trial record 1 of 1 for:
NCT05476926
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER)
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| ClinicalTrials.gov Identifier: NCT05476926 |
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Recruitment Status :
Recruiting
First Posted : July 27, 2022
Last Update Posted : May 9, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 (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. The study start in a country is contingent on the approval of at least one product.
| Condition or disease | Intervention/treatment |
|---|---|
| Neovascular Age-related Macular Degeneration Diabetic Macular Edema | Drug: Faricimab Combination Product: Port Delivery System with Ranibizumab |
| Study Type : | Observational |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY) |
| Actual Study Start Date : | November 21, 2022 |
| Estimated Primary Completion Date : | December 31, 2026 |
| Estimated Study Completion Date : | December 31, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
| Group/Cohort | Intervention/treatment |
|---|---|
| Faricimab for nAMD |
Drug: Faricimab
Faricimab will be administered as per local clinical practice and local labeling.
Other Names:
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| Faricimab for DME |
Drug: Faricimab
Faricimab will be administered as per local clinical practice and local labeling.
Other Names:
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| 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:
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Primary Outcome Measures :
- Change in Visual Acuity per Eye from Baseline at 1 Year, per Approved Retinal Indication and Product [ Time Frame: 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.
Secondary Outcome Measures :
- Change in Visual Acuity per Eye from Baseline Over Time, per Approved Retinal Indication and Product [ Time Frame: Baseline, 3 and 6 months, and 2, 3, 4, and 5 years ]Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
- Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product [ Time Frame: Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years ]
- Number of Treatments per Year, per Approved Retinal Indication and Product [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1, 2, 3, 4, and 5 years ]
- Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product [ Time Frame: 1, 2, 3, 4, and 5 years ]
- Time Interval Between Treatments per Year, per Approved Retinal Indication and Product [ Time Frame: 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 [ Time Frame: From Baseline until end of study (up to 5 years) ]
- Change in Visual Acuity per Eye from Baseline Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other), per Approved Retinal Indication and Product [ Time Frame: Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years ]Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
- Change in Visual Acuity per Eye from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product [ Time Frame: Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years ]Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
- Change in Visual Acuity per Eye from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product [ Time Frame: Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years ]Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
- Change in Visual Acuity per Eye from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product [ Time Frame: Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years ]Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
- Number of Participants with at Least One Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product [ Time Frame: From Baseline until end of study (up to 5 years) ]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.
- Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product [ Time Frame: From Baseline until end of study (up to 5 years) ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Criteria
Inclusion Criteria:
- Have provided informed consent, as required per local regulations
- Adult patients, as defined by local regulations and local product label, who are being treated with any approved Roche ophthalmology product in retinal indication in scope for this study, according to the investigator's discretion in routine clinical practice (irrespective of whether the patient is starting treatment at the time of enrollment or is already receiving treatment). Patients are also considered eligible if they are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication in scope for this study
Exclusion Criteria:
- Concomitant participation 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 in scope for this study)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05476926
Contacts
| Contact: Reference Study ID Number: MR41927 https://forpatients.roche.com/ | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
Locations
Show 19 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT05476926 |
| Other Study ID Numbers: |
MR41927 |
| First Posted: | July 27, 2022 Key Record Dates |
| Last Update Posted: | May 9, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
| 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 |
Additional relevant MeSH terms:
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Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Faricimab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |