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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Genentech, Inc. · Participants: 93 · Started: Apr 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07425522

Locations in the U.S.

ArizonaAssociated Retina Consultants - Peoria - DocTrials - PPDS, Peoria
CaliforniaRetina-Vitreous Associates Medical Group, Beverly Hills
Bay Area Retina Specialists Medical Group - Vestrum - PPDS, Walnut Creek
FloridaRetina Vitreous Associates of Florida, St. Petersburg
MarylandWilmer Eye Institute, Baltimore
PennsylvaniaErie Retina Research, LLC - 300 State St, Erie
Wills Eye Hospital, Philadelphia
TennesseeCharles Retina Institute, Germantown
TexasRetina Research Institute of Texas, Abilene
Austin Clinical Research, LLC, Austin
Retina Consultants of Texas Westover Hills Retina Center, San Antonio
VirginiaPiedmont Eye Center, Lynchburg

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.