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

Roche

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: Faricimab; Procedure: Sham Procedure; Drug: Aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT03622593

GR40398

2017-005105-12 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 951 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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951 participants in 3 patient groups

A: Faricimab 6 mg Q8W

Experimental group

Description:

Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.

Treatment:

Procedure: Sham Procedure

Drug: Faricimab

B: Faricimab 6 mg PTI

Experimental group

Description:

Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.

Treatment:

Procedure: Sham Procedure

Drug: Faricimab

C: Aflibercept 2 mg Q8W

Active Comparator group

Description:

Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.

Treatment:

Drug: Aflibercept

Procedure: Sham Procedure