A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Associated Retina Consultants - Peoria - DocTrials - PPDS
RECRUITING
Peoria
Texas
Retina Research Institute of Texas
RECRUITING
Abilene
Austin Clinical Research, LLC
RECRUITING
Austin
Contact Information
Primary
Reference Study ID Number GR46431 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2028-11-17
Participants
Target number of participants: 93
Treatments
Experimental: Part 1: Multiple Ascending Dose (MAD) Monotherapy
Participants will receive multiple doses of RO7823653, administered as an IVT injection.
Experimental: Part 2: Optional Multiple-Dose Expansion
Participants will receive multiple doses of RO7823653 administered as an IVT injection, at or below the maximum tolerated dose (MTD) or maximum tested dose (MTeD), as determined during the MAD stage.
Experimental: Part 3: MAD (RO7823653 + Faricimab)
Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.