Recruiting

Phase 1

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

Sponsor:

Genentech, Inc.

Code:

NCT07425522

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RO7823653

Faricimab

Study Details

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

Study ID

NCT07425522

Start date

Apr 21, 2026

Status verified date

Aug, 2026

Completion date

Nov 17, 2028

Anticipated

Primary completion date

Nov 17, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

93 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Multiple Ascending Dose (MAD) Monotherapy

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

experimental: Part 2: Optional Multiple-Dose Expansion

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.

experimental: Part 3: MAD (RO7823653 + Faricimab)

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

Interventions

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.

Primary outcome measure

Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs [ Time Frame: Up to approximately 20 Weeks ]

Central Contacts and Locations

Central contacts

Reference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below.

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

Locations

Associated Retina Consultants - Peoria - DocTrials - PPDS

Recruiting

Peoria, Arizona, United States, 85381-3690

Retina-Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211-1838

Bay Area Retina Specialists Medical Group - Vestrum - PPDS

Recruiting

Walnut Creek, California, United States, 94598-5915

Retina Vitreous Associates of Florida

Recruiting

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

Wilmer Eye Institute

Recruiting

Baltimore, Maryland, United States, 21287-0005

Erie Retina Research, LLC - 300 State St

Recruiting

Erie, Pennsylvania, United States, 16507-1429

Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107-5109

Charles Retina Institute

Recruiting

Germantown, Tennessee, United States, 38138-2405

Retina Research Institute of Texas

Recruiting

Abilene, Texas, United States, 79606-1224

Austin Clinical Research, LLC

Recruiting

Austin, Texas, United States, 78750-2298

Retina Consultants of Texas Westover Hills Retina Center

Recruiting

San Antonio, Texas, United States, 78251

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502-4271

More Information

Sponsor

Genentech, Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-08-14.