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

NCT07425522 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GR46431
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs

  Up to approximately 20 Weeks

Secondary Outcomes (6)

• 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

Study Arms (3)

Part 1: Multiple Ascending Dose (MAD) Monotherapy

EXPERIMENTAL

Participants will receive multiple doses of RO7823653, administered as an IVT injection.

Drug: RO7823653

Part 2: Optional Multiple-Dose Expansion

EXPERIMENTAL

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

Part 3: MAD (RO7823653 + Faricimab)

EXPERIMENTAL

Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.

Drug: RO7823653; Drug: Faricimab

Interventions

RO7823653 DRUG

Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.

Part 1: Multiple Ascending Dose (MAD) Monotherapy; Part 2: Optional Multiple-Dose Expansion; Part 3: MAD (RO7823653 + Faricimab)

Faricimab DRUG

Participants will receive faricimab as an IVT injection per the schedule described in the protocol.

Part 3: MAD (RO7823653 + Faricimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (8)

Associated Retina Consultants - Peoria - DocTrials - PPDS

Peoria, Arizona, 85381-3690, United States

RECRUITING

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211-1838, United States

RECRUITING

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711-1141, United States

RECRUITING

Erie Retina Research, LLC - 300 State St

Erie, Pennsylvania, 16507-1429, United States

RECRUITING

Retina Research Institute of Texas

Abilene, Texas, 79606-1224, United States

RECRUITING

Austin Clinical Research, LLC

Austin, Texas, 78750-2298, United States

RECRUITING

Retina Consultants of Texas Westover Hills Retina Center

San Antonio, Texas, 78251, United States

RECRUITING

Piedmont Eye Center

Lynchburg, Virginia, 24502-4271, United States

RECRUITING

MeSH Terms

Interventions

faricimab

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number GR46431 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): November 17, 2028
• Study Completion (Estimated): November 17, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)