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NCT07425522PHASE1Recruiting

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

Genentech, Inc.

Start Date

4/21/2026

Completion Date

11/17/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

RO7823653

DRUG

Faricimab

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Conditions

Diabetic Macular Edema

Locations

Associated Retina Consultants - Peoria - DocTrials - PPDS

Peoria, Arizona 85381-3690

United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California 90211-1838

United States

Bay Area Retina Specialists Medical Group - Vestrum - PPDS

Walnut Creek, California 94598-5915

United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida 33711-1141

United States

Erie Retina Research, LLC - 300 State St

Erie, Pennsylvania 16507-1429

United States

Charles Retina Institute

Germantown, Tennessee 38138-2405

United States

Retina Research Institute of Texas

Abilene, Texas 79606-1224

United States

Austin Clinical Research, LLC

Austin, Texas 78750-2298

United States

Retina Consultants of Texas Westover Hills Retina Center

San Antonio, Texas 78251

United States

Piedmont Eye Center

Lynchburg, Virginia 24502-4271

United States