Overview

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

Status:
Completed
Trial end date:
2021-09-03
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Aflibercept
Criteria
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