Actively Recruiting
A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of RO7823653 by Intravitreal Injection Alone and With Faricimab in Patients With Diabetic Macular Edema
Led by Genentech, Inc. · Updated on 2026-05-20
93
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of multiple doses of RO7823653 in adults with diabetic macular edema (DME). The study investigates RO7823653 given by intravitreal injection both alone and in combination with faricimab to better understand its effects in people with this eye condition. Participants will receive multiple injections of RO7823653, either as monotherapy or combined with faricimab, administered directly into the eye. The study includes a multiple ascending dose (MAD) stage to determine the maximum tolerated or tested dose before proceeding. There are three parts: RO7823653 alone, an optional expansion stage, and RO7823653 combined with faricimab. During the study, participants will be closely monitored for eye and systemic adverse events for up to about 20 weeks. Researchers will measure drug levels in blood and eye fluid, check for immune responses against the drug, and assess changes in vision and retinal thickness. Safety and tolerability are key outcomes, with regular assessments to understand the treatment effects and guide dosing recommendations.
CONDITIONS
Brief 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) less than or equal to 12%
- Macular thickening secondary to diabetic macular edema involving the center of the fovea with central subfield thickness greater than or equal to 325 micrometers as measured by SD-OCT
- Best-corrected visual acuity (BCVA) score between 65 and 35 letters in the study eye
- Age 18 years or older
You will not qualify if you...
- Untreated diabetes mellitus or started oral anti-diabetic medication or insulin within 90 days prior to Day 1
- Pregnant, breastfeeding, or planning pregnancy during study or required contraception period
- Uncontrolled blood pressure
- For Parts 1 and 2: History of ocular injection or implant therapy such as anti-VEGF, corticosteroids, or device implants
- For Part 3: Treatment with aflibercept 2 mg, ranibizumab, bevacizumab, anti-VEGF biosimilars within 90 days prior to Day 1; aflibercept 8 mg, brolucizumab, faricimab within 120 days; triamcinolone acetonide within 120 days; dexamethasone implant within 180 days; fluocinolone acetonide implant within 3 years; or device implant
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 20 weeks
Participants receive multiple doses of RO7823653, alone or with faricimab, administered by intravitreal injection according to the dosing schedule.
Multiple visits for dosing and assessments during the treatment period
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/
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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