A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.

Eligibility criteria

Qualifiers

Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association

Glycated hemoglobin (HbA1c) <= 12%

For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) >= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters

Disqualifiers

Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1

Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required

Uncontrolled blood pressure

For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.

Trial design

Treatments tested in this trial

  • RO7823653
  • Faricimab

Treatment groups

93 Participants
are divided into 3 treatment groups

Sponsors and collaborators