Testing RO7823653 eye injections, alone and with faricimab, in diabetic macular edema
Tests RO7823653 injected into the eye, alone or with faricimab, in diabetic macular edema.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
Key facts
- Where
- Abilene, Austin, Baltimore, Beverly Hills, Erie, Germantown, Lynchburg, Peoria, Philadelphia, San Antonio, St. Petersburg, and Walnut Creek, United StatesSee the 12 sites
- Phase
- Phase 1
Where in United States
- Retina Research Institute of TexasAbilene, United StatesTaking people
- Austin Clinical Research, LLCAustin, United StatesTaking people
- Wilmer Eye InstituteBaltimore, United StatesTaking people
- Retina-Vitreous Associates Medical GroupBeverly Hills, United StatesTaking people
- Erie Retina Research, LLC - 300 State StErie, United StatesTaking people
- Charles Retina InstituteGermantown, United StatesTaking people
- Piedmont Eye CenterLynchburg, United StatesTaking people
- Associated Retina Consultants - Peoria - DocTrials - PPDSPeoria, United StatesTaking people
- Wills Eye HospitalPhiladelphia, United StatesTaking people
- Retina Consultants of Texas Westover Hills Retina CenterSan Antonio, United StatesTaking people
- Retina Vitreous Associates of FloridaSt. Petersburg, United StatesTaking people
- Bay Area Retina Specialists Medical Group - Vestrum - PPDSWalnut Creek, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech, Inc.
- Trial code
- NCT07425522
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1; 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; Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye; 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; History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye; Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required; Uncontrolled blood pressure; Active intraocular inflammation in either eye.