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NCT07425522RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
93 (estimated)
First submitted
16 Feb 2026
Start date
Apr 2026
Primary completion date
Nov 2028
Lead sponsor
Genentech, Inc.
NCT number
NCT07425522

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 93
  • From Apr 2026 to the primary completion date, Nov 2028
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Retina Research Institute of Texas
Coordinator of this site? Confirm its status
AbileneUnited StatesRecruiting
Austin Clinical Research, LLC
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Wilmer Eye Institute
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Retina-Vitreous Associates Medical Group
Coordinator of this site? Confirm its status
Beverly HillsUnited StatesRecruiting
Erie Retina Research, LLC - 300 State St
Coordinator of this site? Confirm its status
ErieUnited StatesRecruiting
Charles Retina Institute
Coordinator of this site? Confirm its status
GermantownUnited StatesRecruiting
Piedmont Eye Center
Coordinator of this site? Confirm its status
LynchburgUnited StatesRecruiting
Associated Retina Consultants - Peoria - DocTrials - PPDS
Coordinator of this site? Confirm its status
PeoriaUnited StatesRecruiting
Wills Eye Hospital
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Retina Consultants of Texas Westover Hills Retina Center
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Retina Vitreous Associates of Florida
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting
Bay Area Retina Specialists Medical Group - Vestrum - PPDS
Coordinator of this site? Confirm its status
Walnut CreekUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.