RO7823653 injections, alone or with faricimab, for diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial administers multiple intravitreal doses of RO7823653 as monotherapy and co-administered with faricimab in adults with center-involving diabetic macular edema. The primary goals are to characterize safety and tolerability and to measure pharmacokinetics (PK) and pharmacodynamics (PD) of RO7823653 in the eye. Participants are enrolled into cohorts including treatment-naïve and previously treated eyes, with scheduled SD-OCT imaging and best-corrected visual acuity assessments over follow-up visits. Key entry criteria include central subfield thickness ≥325 µm and BCVA between 65 and 35 letters, and the protocol excludes recent initiation of diabetes medications, uncontrolled blood pressure, pregnancy, and (for early cohorts) prior ocular injection or implant therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• Associated Retina Consultants - Peoria - DocTrials - PPDS
  Peoria, Arizona, United States Recruiting
• Retina-Vitreous Associates Medical Group
  Beverly Hills, California, United States Recruiting
• Bay Area Retina Specialists Medical Group - Vestrum - PPDS
  Walnut Creek, California, United States Recruiting
• Retina Vitreous Associates of Florida
  St. Petersburg, Florida, United States Recruiting
• Wilmer Eye Institute
  Baltimore, Maryland, United States Recruiting
• Erie Retina Research, LLC - 300 State St
  Erie, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.