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Clinical Trials in the USA / NCT07425522
Recruiting Phase 1

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

NCT07425522 · tracked via the Priya Life Science USA tracker
Sponsor
Genentech, Inc.
Phase
Phase 1
Started
2026-04-21
Last updated
2026-09-11

Condition(s) studied

Diabetic Macular Edema

Investigational drug(s) / intervention(s)

RO7823653Faricimab

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Associated Retina Consultants - Peoria - DocTrials - PPDS Peoria Arizona Recruiting
Retina-Vitreous Associates Medical Group Beverly Hills California Recruiting
Bay Area Retina Specialists Medical Group - Vestrum - PPDS Walnut Creek California Recruiting
Retina Vitreous Associates of Florida St. Petersburg Florida Recruiting
Wilmer Eye Institute Baltimore Maryland Recruiting
Erie Retina Research, LLC - 300 State St Erie Pennsylvania Recruiting
Wills Eye Hospital Philadelphia Pennsylvania Recruiting
Charles Retina Institute Germantown Tennessee Recruiting
Retina Research Institute of Texas Abilene Texas Recruiting
Austin Clinical Research, LLC Austin Texas Recruiting
Retina Consultants of Texas Westover Hills Retina Center San Antonio Texas Recruiting
Piedmont Eye Center Lynchburg Virginia Recruiting

More Genentech, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07425522 on ClinicalTrials.gov ↗ ← All trials in the USA