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

• Status: Active, not recruiting
• Trial end date: 2023-07-01
• 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 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