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

Conditions

• Diabetic Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Faricimab — DRUG
  Faricimab will be administered by IVT injection in the study eye.
• Ranibizumab — DRUG
  Ranibizumab will be administered by IVT injection in the study eye.

Study Details

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.

Key Dates

First listed

Mar 4, 2016

Start date

Apr 27, 2016

Status verified

Aug 2020

Primary completion

Sep 15, 2017

Completion

Dec 14, 2017

Study Design

Enrollment

229 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: 0.3 mg Ranibizumab
  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.
• Experimental: Arm B: 1.5 mg Faricimab
  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.
• Experimental: Arm C: 6 mg Faricimab
  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.

Primary Outcome Measure

Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants [ Time Frame: Baseline, Week 24 ]

Locations (60)

Find similar trials in Phoenix, AZ

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