A study to evaluate the long-term safety and tolerability of faricimab administered in patients previously enrolled in Roche-sponsored studies
| ISRCTN | ISRCTN14123846 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14123846 |
| Secondary identifying numbers | YR42837 |
- Submission date
- 12/07/2021
- Registration date
- 06/08/2021
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims:
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.
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)
Contact information
Public
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +41 616878333 |
|---|---|
| global.trial_information@roche.com |
Study information
| Study design | Non-randomized open-label multicenter standalone extension study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific 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 |
| Study objectives | To investigate the long-term safety and tolerability of faricimab administered in patients previously enrolled in Roche-sponsored studies |
| Ethics approval(s) | Approved 05/03/2021, Shanghai General Hospital Institutional Review Board (No. 100, Haining Road, Shanghai, 200080, China; +86-21-36123569; Shiyilunli@sina.com), ref: [2021]026 |
| Health condition(s) or problem(s) studied | Macular degeneration |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Faricimab (RO6867461) |
| Primary outcome measure | 1. Eye condition measured using BCVA, pre-treatment IOP, slit-lamp examination, and Indirect ophthalmoscopy measured at baseline (Day 1) and each visit which is in the range of 21 days to 4 months 2. Effect of drug measured using finger-counting test and IOP (post-study treatment) are measured after each administration. As the study drug administration has no mandatory timepoint and is decided by the clinical judgment of the investigator, these assessments have no specified timepoint 3. Other eye tests, SD-OCT, CFP, and FFA are also measured according to the investigator's discretion, they have no specified timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 17/08/2020 |
| Completion date | 04/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 350 |
| Key inclusion criteria | 1. Previous enrollment in and completion of any faricimab parent study without study or study drug discontinuation. 2. Enrolled in the mainland of China 3. Signed Informed Consent Form 4. Ability and willingness to comply with the study protocol, in the investigator's judgment |
| Key exclusion criteria | 1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final ITV injection of faricimab 2. Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. |
| Date of first enrolment | 19/07/2021 |
| Date of final enrolment | 04/04/2025 |
Locations
Countries of recruitment
- China
Study participating centre
201620
China
Sponsor information
Industry
Grenzacherstrasse 124
Basel
4070
Switzerland
| Phone | +41 616878333 |
|---|---|
| global.trial_information@roche.com | |
| Website | http://www.roche.com/about_roche/roche_worldwide.htm |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Genentech, Inc., Genentech USA, Inc., Genentech USA
- Location
- United States of America
Results and Publications
| Intention to publish date | 04/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to there being no regulatory requirement to do so. |
Editorial Notes
05/12/2023: The following changes were made:
1. Study website added.
2. The study and sponsor contacts were updated.
19/07/2021: Trial's existence confirmed by Shanghai General Hospital Institutional Review Board.
