A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
Genentech, Inc. · NCT07425522
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 93
- US sites recruiting
- 12
- Study start
- April 21, 2026
- Record last updated
- October 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: RO7823653; Faricimab
Conditions: Diabetic Macular Edema
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Associated Retina Consultants - Peoria - DocTrials - PPDS
Peoria, AZ 85381-3690
Retina-Vitreous Associates Medical Group
Beverly Hills, CA 90211-1838
Bay Area Retina Specialists Medical Group - Vestrum - PPDS
Walnut Creek, CA 94598-5915
Retina Vitreous Associates of Florida
St. Petersburg, FL 33711-1141
Wilmer Eye Institute
Baltimore, MD 21287-0005
Erie Retina Research, LLC - 300 State St
Erie, PA 16507-1429
Wills Eye Hospital
Philadelphia, PA 19107-5109
Charles Retina Institute
Germantown, TN 38138-2405
Retina Research Institute of Texas
Abilene, TX 79606-1224
Austin Clinical Research, LLC
Austin, TX 78750-2298
Retina Consultants of Texas Westover Hills Retina Center
San Antonio, TX 78251
Piedmont Eye Center
Lynchburg, VA 24502-4271
Study contacts (from the official record)
- 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
- Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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