Last updated on May 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetic Macular Edema
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to () 10%
  • 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 anti-diabetic medication or insulin 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.