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A study to evaluate the long-term safety and tolerability of faricimab administered in patients previously enrolled in Roche-sponsored studies
An open-label, multicenter extension study to evaluate the long-term safety and tolerability of faricimab administered in patients previously enrolled in studies sponsored by F. Hoffmann-La Roche Ltd
- Eye Disorder
- Age-Related Macular Degeneration
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Recruiting
This trial runs in
Country
- China
Trial Identifier:
YR42837
Trial Summary
The purpose of this study is to assess long-term safety of faricimab therapy and provide access to continued treatment with faricimab, as applicable, to patients with Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (nAMD), or Retinal Vein Occlusion (RVO).
Faricimab is an experimental drug, which means health authorities have not approved it for the treatment of DME, nAMD, or RVO outside of a clinical study. As of November 2020, more than 3,350 patients have been enrolled in either the completed or ongoing clinical studies of faricimab in patients with DME and nAMD. Of these patients, more than 2,100 patients have received at least one dose of faricimab.
F. Hoffmann-La Roche Ltd (Switzerland), Genentech Inc (USA)
Sponsor
YR42837
Trial Identifier
Both
Gender
Mixed
Age
No
Healthy Volunteers
Who can participate?
Patients who were previously enrolled in the mainland of China and completed any of Roche-sponsored faricimab parent trials
What does the study involve?
Participants will be placed in a single treatment group:
Participants will receive faricimab 6 mg injections into the study eye at a variable interval depending on the condition of their eye. Frequency of injections will be determined by the study doctor, usually varying between every 4 weeks and every 16 weeks.
Participants will only be required to attend the clinic according to the study doctor’s discretion, but the interval between visits should be no more than 4 months and no less than 21 days.
What are the possible benefits and risks of participating?
Your health may or may not improve in this study, but the information that is learned may help other people who have a similar medical condition in the future.
You may have side effects from the drugs or procedures used in this study. Side effects can be mild to severe and even life threatening, and they can vary from person to person. There may be a risk in exposing an unborn child to the study drug, and all risks are not known at this time. Women and men must take precautions to avoid exposing an unborn child to the study drug.
Where is the study run from?
Shanghai General Hospital (China)
When is the study starting and how long is it expected to run for?
August 2020 to August 2025
Who is funding the study?
F. Hoffmann-La Roche Ltd (Switzerland)
Genentech Inc (USA)
Trial Summary
The purpose of this study is to assess long-term safety of faricimab therapy and provide access to continued treatment with faricimab, as applicable, to patients with Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (nAMD), or Retinal Vein Occlusion (RVO).
Faricimab is an experimental drug, which means health authorities have not approved it for the treatment of DME, nAMD, or RVO outside of a clinical study. As of November 2020, more than 3,350 patients have been enrolled in either the completed or ongoing clinical studies of faricimab in patients with DME and nAMD. Of these patients, more than 2,100 patients have received at least one dose of faricimab.
F. Hoffmann-La Roche Ltd (Switzerland), Genentech Inc (USA)
Sponsor
YR42837
Trial Identifier
Faricimab (RO6867461)
Treatments
Macular degeneration
Condition
Official Title
An open-label, multicenter extension study to evaluate the long-term safety and tolerability of faricimab administered in patients previously enrolled in studies sponsored by F. Hoffmann-La Roche Ltd
Eligibility Criteria
Both
Gender
Mixed
Age
No
Healthy Volunteers
For the latest version of this information please go to www.forpatients.roche.com