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A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
Sponsor: Genentech, Inc.
Summary
This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.
Official title: A Phase I, Multipart, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7497372 Following Intravitreal Administration in Participants With Diabetic Macular Edema (Part 1 Non-Randomized, Open-Label, Multiple Ascending Dose; Part 2 Randomized, Double-Masked)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
151
Start Date
2022-12-08
Completion Date
2027-04-30
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
RO7497372
RO7497372 will be administered as IVT injection as per the schedule specified in the arms.
Locations (38)
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
Retinal Consultants of AZ, Ltd
Peoria, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Arkansas Retina Research
Little Rock, Arkansas, United States
Global Research Management
Glendale, California, United States
Retinal Consultants Medical Group
Modesto, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Florida Eye Associates
Melbourne, Florida, United States
Medeye Associates
Miami, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Retina Specialists of Tampa
Wesley Chapel, Florida, United States
Center for Retina and Macula Disease
Winter Haven, Florida, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
Retina Associates of Michigan
Grand Blanc, Michigan, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
Retina Consultants Minnesota
Saint Louis Park, Minnesota, United States
Mississippi Retina Associates
Madison, Mississippi, United States
The Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Ross Eye Institute
Buffalo, New York, United States
Retina Associates of NY
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Verum Research LLC
Eugene, Oregon, United States
EyeHealth Northwest
Portland, Oregon, United States
Erie Retinal Surgery
Erie, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States
Charles Retina Institute
Germantown, Tennessee, United States
Austin Clinical Research LLC
Austin, Texas, United States
Brown Retina Institute
Schertz, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Salt Lake Retina
West Jordan, Utah, United States
Retina Group of Washington
Fairfax, Virginia, United States
Emerson Clinical Research Institute
Falls Church, Virginia, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Institute
Norfolk, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Emanuelli Research and Development Center
Arecibo, Puerto Rico