RO7823653 injections, alone or with faricimab, for diabetic macular edema
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
This research tests injections of RO7823653, given alone or with faricimab, in people with diabetic macular edema to see if the medication is safe and how the eye handles it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Drugs / interventions | ranibizumab, bevacizumab, brolucizumab, faricimab |
| Locations | 8 sites (Peoria, Arizona and 7 other locations) |
| Trial ID | NCT07425522 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with center-involving diabetic macular edema, central subfield thickness ≥325 µm, BCVA roughly 65–35 letters, HbA1c ≤12%, and the ability to attend regular in-person injection and follow-up visits are the ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have uncontrolled blood pressure, recently started diabetes medications or insulin within 90 days, or (for early cohorts) have prior ocular injection/implant treatments are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify a safe dose and dosing approach that may provide a new local treatment option for DME, alone or in combination with faricimab.
How similar studies have performed: Faricimab and other anti-VEGF/Ang-2 therapies have shown benefit for DME in prior trials, but RO7823653 is investigational and combination approaches with this molecule remain unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Peoria, Arizona and 7 other locations
- Associated Retina Consultants - Peoria - DocTrials - PPDS — Peoria, Arizona, United States (Recruiting)
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
- Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States (Recruiting)
- Erie Retina Research, LLC - 300 State St — Erie, Pennsylvania, United States (Recruiting)
- Retina Research Institute of Texas — Abilene, Texas, United States (Recruiting)
- Austin Clinical Research, LLC — Austin, Texas, United States (Recruiting)
- Retina Consultants of Texas Westover Hills Retina Center — San Antonio, Texas, United States (Recruiting)
- Piedmont Eye Center — Lynchburg, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number GR46431 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.