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.
- Diseases
- Diabetic eye disease
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Research Institute of Texas Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Austin Clinical Research, LLC Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Wilmer Eye Institute Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Erie Retina Research, LLC - 300 State St Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| Charles Retina Institute Coordinator of this site? Confirm its status | Germantown | United States | Recruiting |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Recruiting |
| Associated Retina Consultants - Peoria - DocTrials - PPDS Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Wills Eye Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Retina Consultants of Texas Westover Hills Retina Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Bay Area Retina Specialists Medical Group - Vestrum - PPDS Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.