A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653… (NCT07425522) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
United States93 participantsStarted 2026-04-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tr…
What they're measuring
1
Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs
Timeframe: Up to approximately 20 Weeks
Trial details
NCT IDNCT07425522
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-11-17
Contact for this trial
Reference Study ID Number GR46431 https://forpatients.roche.com/