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

NCT03622580

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Diabetic Macular Edema

Interventions: Aflibercept, Faricimab, Sham Procedure

Countries: United States, Austria, Bulgaria, France, Germany, Hungary, Israel, Italy

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (185)

Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Campbell, California, United States
Fresno, California, United States
Oakland, California, United States
Palm Desert, California, United States
Pasadena, California, United States
Poway, California, United States
Redlands, California, United States
Riverside, California, United States
Sacramento, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Lakewood, Colorado, United States
Deerfield Beach, Florida, United States
Palm Beach Gardens, Florida, United States
Pensacola, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
‘Aiea, Hawaii, United States
Indianapolis, Indiana, United States
West Des Moines, Iowa, United States
Lenexa, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Paducah, Kentucky, United States
Portland, Maine, United States
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