Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
Led by Genentech, Inc. · Updated on 2026-04-23
93
Participants Needed
8
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diabetes mellitus (type 1 or type 2) as defined by WHO or American Diabetes Association
- Glycated hemoglobin (HbA1c) 12% or less
- Macular thickening due to diabetic macular edema involving the center of the fovea with central subfield thickness 325 micrometers or more
- Best corrected visual acuity (BCVA) of 65 to 35 letters in the study eye
You will not qualify if you...
- Untreated diabetes mellitus or started oral anti-diabetic medication or insulin within 90 days before Day 1
- Pregnant, breastfeeding, or planning pregnancy during the study or contraception period
- Uncontrolled blood pressure
- History of ocular injection or implant therapy for Parts 1 and 2
- For Part 3, recent treatment with specific anti-VEGF agents, corticosteroids, or device implants within specified time frames before Day 1
- History of uveitis, vitritis (grade trace or above), or scleritis in either eye
- Active intraocular inflammation in either eye
- Any previously documented or current proliferative diabetic retinopathy in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Associated Retina Consultants - Peoria - DocTrials - PPDS
Peoria, Arizona, United States, 85381-3690
Actively Recruiting
2
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211-1838
Actively Recruiting
3
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711-1141
Actively Recruiting
4
Erie Retina Research, LLC - 300 State St
Erie, Pennsylvania, United States, 16507-1429
Actively Recruiting
5
Retina Research Institute of Texas
Abilene, Texas, United States, 79606-1224
Actively Recruiting
6
Austin Clinical Research, LLC
Austin, Texas, United States, 78750-2298
Actively Recruiting
7
Retina Consultants of Texas Westover Hills Retina Center
San Antonio, Texas, United States, 78251
Actively Recruiting
8
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502-4271
Actively Recruiting
Research Team
R
Reference Study ID Number GR46431 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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