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

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients With Diabetic Macular Edema (YOSEMITE)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224090

Enrollment

900

Registered

2018-10-15

Start date

2019-02-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic macular edema

Interventions

investigational material(s) Generic name etc : RO6867461 INN of investigational material : Faricimab Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Type 1 or type 2 diabetes mellitus - Hemoglobin A1c (HbA1c) of less than or equal to <=10% - Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea - Ability and willingness to undertake all scheduled visits and assessments

Exclusion criteria

Exclusion criteria: - Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin 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 - Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye - Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to 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

Design outcomes

Primary

Measure	Time frame
efficacy Average change from baseline in BCVA at 1 year	—

Secondary

Measure	Time frame
safety efficacy - Change from baseline in BCVA over time - Percentage of Participants With a >=2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year - Percentage of Participants Gaining >=15, >=10, >=5 or >=0 Letters in BCVA From Baseline Over Time - Change from baseline in CST over time - Change from baseline in NEI VFQ-25 composite score over time - Percentage of Participants With Ocular Adverse Events - Percentage of Participants With Non-Ocular Adverse Events	—

Measure

Time frame

safety efficacy - Change from baseline in BCVA over time - Percentage of Participants With a >=2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year - Percentage of Participants Gaining >=15, >=10, >=5 or >=0 Letters in BCVA From Baseline Over Time - Change from baseline in CST over time - Change from baseline in NEI VFQ-25 composite score over time - Percentage of Participants With Ocular Adverse Events - Percentage of Participants With Non-Ocular Adverse Events

—

Countries

Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026