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A clinical trial to compare faricimab with aflibercept in people with diabetic macular edema. (Yosemite)
A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants With Diabetic Macular Edema (YOSEMITE)
- Eye Disorder
- Diabetic Macular Edema
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:
Completed
This trial runs in
Countries
- Austria
- Bulgaria
- France
- Germany
- Hungary
- Israel
- Italy
- Japan
- Mexico
- Peru
- Poland
- Russia
- Slovakia
- Spain
- Turkey
- United States
Trial Identifier:
NCT03622580 2017-005104-10 GR40349
Trial Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03622580,GR40349,2017-005104-10
Trial Identifier
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
How does the YOSEMITE clinical trial work?
This clinical trial is recruiting people who have a type of disease called diabetic macular edema or DME.
The purpose of this clinical trial is to compare the effects, good or bad, of faricimab versus aflibercept in patients with DME. In this clinical trial, you will get either faricimab or aflibercept as treatment.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have been diagnosed with diabetic macular edema. You must also be taking regular treatment for your diabetes.
If you have previously been given faricimab in either eye, have uncontrolled blood pressure or other eye-related problems, you will not be able to join the trial.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will be split into 1 of 3 groups randomly and given either:
- faricimab, given as an injection into your eye every 8 weeks
- OR faricimab, given as an injection into your eye (the time between injections will be based on how your disease responds to the treatment and will vary throughout the trial)
- OR aflibercept, given as an injection into your eye every 8 weeks
You will have a one in three chance of being placed in any group. Only one eye will be treated during the study. If you have DME in both eyes, the eye that has the worst vision will be treated with the clinical trial drug and you will be given the current standard treatment for your other eye.
Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in, if your safety is at risk. As the times between treatments are different for each group, you will have to have a sham treatment during the visits where you do not need your treatment to make sure that nobody knows which group you are in.
How often will I be seen in follow-up appointments, and for how long?
You will be given the clinical trial treatment faricimab OR aflibercept for just under 2 years (96 weeks). You are free to stop this treatment at any time. After being given your last treatment, you will be seen once more by the clinical trial doctor after 4 weeks. This hospital visit will include checks to see how you are responding to the treatment and monitor any side effects that you may be having.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov
Trial-identifier: NCT03622580
Trial Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03622580,GR40349,2017-005104-10
Trial Identifier
Aflibercept, RO6867461, Sham Procedure
Treatments
Diabetic Macular Edema
Condition
Official Title
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
Eligibility Criteria
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion Criteria
- Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
- Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
- Prior administration of IVT faricimab in either eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- Other protocol-specified inclusion/exclusion criteria may apply
For the latest version of this information please go to www.forpatients.roche.com