RecruitingPhase 1NCT07425522

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


Sponsor

Genentech, Inc.

Enrollment

93 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Faricimab and a drug called RO7823653 for people with diabetic macular edema. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7823653

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

DRUGFaricimab

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


Locations(12)

Associated Retina Consultants - Peoria - DocTrials - PPDS

Peoria, Arizona, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Bay Area Retina Specialists Medical Group - Vestrum - PPDS

Walnut Creek, California, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Wilmer Eye Institute

Baltimore, Maryland, United States

Erie Retina Research, LLC - 300 State St

Erie, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Charles Retina Institute

Germantown, Tennessee, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Austin Clinical Research, LLC

Austin, Texas, United States

Retina Consultants of Texas Westover Hills Retina Center

San Antonio, Texas, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07425522


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