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Roche YOSEMITE - Diabetic Macular Edema

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

Study Description:

Condition or DiseaseIntervention / Treatment PhaseSponsor Status 
 Diabetic Macular EdemaDrug: Faricimab
Drug:  Aflibercept
Sham
 Hoffman-LaRoche Enrolling

 

 

  

 

 

 

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). 

Inclusion Criteria:

  • Age 18 Years or older.
  • 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 the past 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.

Contact:  Beachwood Office:  Dianne Himmelman 216-831-5700    dhimmelman@retina-assoc.com.  

To learn more: https://clinicaltrials.gov/ct2/show/NCT03622580?term=yosemite&rank=1