A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Aflibercept; Faricimab; Sham Procedure
Intervention description: Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).; Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.; The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
Intervention MeSH terms: Aflibercept; Faricimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 940.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

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