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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: RO7823653; Drug: Faricimab

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Reference Study ID Number GR46431 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• United States
  • Arizona
    • Peoria, Arizona, United States, 85381-3690
      • Recruiting
      • Associated Retina Consultants - Peoria - DocTrials - PPDS
  • California
    • Beverly Hills, California, United States, 90211-1838
      • Recruiting
      • Retina-Vitreous Associates Medical Group
  • Florida
    • St. Petersburg, Florida, United States, 33711-1141
      • Recruiting
      • Retina Vitreous Associates of Florida
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507-1429
      • Recruiting
      • Erie Retina Research, LLC - 300 State St
  • Texas
    • Abilene, Texas, United States, 79606-1224
      • Recruiting
      • Retina Research Institute of Texas
    • Austin, Texas, United States, 78750-2298
      • Recruiting
      • Austin Clinical Research, LLC
    • San Antonio, Texas, United States, 78251
      • Recruiting
      • Retina Consultants of Texas Westover Hills Retina Center
  • Virginia
    • Lynchburg, Virginia, United States, 24502-4271
      • Recruiting
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant
• History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye
• Active intraocular inflammation in either eye
• Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Multiple Ascending Dose (MAD) Monotherapy; Participants will receive multiple doses of RO7823653, administered as an IVT injection.	Drug: RO7823653; Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
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.	Drug: RO7823653; Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
Experimental: Part 3: MAD (RO7823653 + Faricimab); Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.	Drug: RO7823653; Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.; Drug: Faricimab; Participants will receive faricimab as an IVT injection per the schedule described in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs	Up to approximately 20 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Concentrations of RO7823653	Up to approximately 20 Weeks
Aqueous Humor Concentrations of RO7823653	Up to approximately 20 Weeks
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653	Up to approximately 20 Weeks
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score	Up to approximately 20 Weeks
Change From Baseline in Retinal Thickness	Up to approximately 20 Weeks
Recommended Dose of RO7823653	Up to approximately 20 Weeks

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2026
• Primary Completion (Estimated): November 17, 2028
• Study Completion (Estimated): November 17, 2028

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: faricimab
• Other Study ID Numbers: GR46431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No