A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (HbA1c) \< 12%
Macular thickening secondary to DME involving the center of the fovea \> 325 microns
Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters
You may not be if
Currently untreated DM or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1
Uncontrolled blood pressure (BP)
Pregnancy or breastfeeding, or intention to become pregnant during the study
For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5: IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatment prior to Day 1 for treatment naïve participants
Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1
Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior to Day 1
Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
Proliferative diabetic retinopathy (PDR) in the study eye
Clareo Health | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
