A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema (BOULEVARD)

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Faricimab; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02699450

BP30099

RG7716 (Other Identifier)

Details and patient eligibility

About

This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Macular edema associated with diabetic retinopathy
• Decreased visual acuity attributable primarily to DME
• Diagnosis of diabetes mellitus

Exclusion criteria

• High risk proliferative diabetic retinopathy
• Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery
• Uncontrolled glaucoma
• Current or history of ocular disease in the study eye other than DME
• Major illness or major surgical procedure within 1 month prior to Day 1
• Uncontrolled blood pressure
• Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening
• Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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229 participants in 3 patient groups

Arm A: 0.3 mg Ranibizumab

Active Comparator group

Description:

Participants will receive 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.

Treatment:

Drug: Ranibizumab

Arm B: 1.5 mg Faricimab

Experimental group

Description:

Participants will receive 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.

Treatment:

Drug: Faricimab

Arm C: 6 mg Faricimab

Experimental group

Description:

Participants will receive 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.

Treatment:

Drug: Faricimab