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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Associated Retina Consultants - Peoria - DocTrials - PPDS
Peoria, Arizona, United States
RECRUITINGRetina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs
Time frame: Up to approximately 20 Weeks
Serum Concentrations of RO7823653
Time frame: Up to approximately 20 Weeks
Aqueous Humor Concentrations of RO7823653
Time frame: Up to approximately 20 Weeks
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653
Time frame: Up to approximately 20 Weeks
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score
Time frame: Up to approximately 20 Weeks
Change From Baseline in Retinal Thickness
Time frame: Up to approximately 20 Weeks
Recommended Dose of RO7823653
Time frame: Up to approximately 20 Weeks
Reference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below.
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Bay Area Retina Specialists Medical Group - Vestrum - PPDS
Walnut Creek, California, United States
RECRUITINGRetina Vitreous Associates of Florida
St. Petersburg, Florida, United States
RECRUITINGWilmer Eye Institute
Baltimore, Maryland, United States
RECRUITINGErie Retina Research, LLC - 300 State St
Erie, Pennsylvania, United States
RECRUITINGWills Eye Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGCharles Retina Institute
Germantown, Tennessee, United States
RECRUITINGRetina Research Institute of Texas
Abilene, Texas, United States
RECRUITINGAustin Clinical Research, LLC
Austin, Texas, United States
RECRUITING...and 2 more locations