A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema
Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (HbA1c) \< 12%
• Macular thickening secondary to DME involving the center of the fovea \> 325 microns
• Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters
Locations
United States
Arizona
Arizona Retina and Vitreous Consultants
RECRUITING
Phoenix
Associated Retinal Consultants PC
RECRUITING
Phoenix
Barnet Dulaney Perkins Eye Center
WITHDRAWN
Phoenix
Retinal Research Institute, LLC
RECRUITING
Phoenix
California
Retinal Diagnostic Center
RECRUITING
Campbell
The Retina Partners
WITHDRAWN
Encino
Retina Consultants of Orange County
RECRUITING
Fullerton
Retinal Consultants Medical Group
RECRUITING
Modesto
Northern California Retina-Vitreous Associates
RECRUITING
Mountain View
Retinal Consultants Medical Group
RECRUITING
Sacramento
Macula Retina Vitreous Research Institute
RECRUITING
Torrance
Colorado
University of Colorado - Eye Center - PPDS
RECRUITING
Aurora
Retina Consultants of Southern Colorado PC
RECRUITING
Colorado Springs
Retina Specialists of Colorado
RECRUITING
Denver
Advanced Vision Research Institute
RECRUITING
Longmont
Connecticut
Retina Group of New England
RECRUITING
Waterford
Florida
Blue Ocean Clinical Research
RECRUITING
Clearwater
National Ophthalmic Research Institute
RECRUITING
Fort Myers
Florida Retina Institute
RECRUITING
Jacksonville
Retina Associates of Florida;Retina Associates of Florida
RECRUITING
Tampa
Georgia
Southeast Retina Center
RECRUITING
Augusta
Georgia Retina PC
RECRUITING
Marietta
Hawaii
Retina Consultants of Hawaii
RECRUITING
‘aiea
Illinois
Illinois Eye and Ear Infirmary
RECRUITING
Chicago
University Retina and Macula Associates, PC
RECRUITING
Oak Forest
Indiana
Raj K. Maturi, MD PC
COMPLETED
Indianapolis
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
The Retina Care Center
RECRUITING
Baltimore
Retina Group of Washington
RECRUITING
Chevy Chase
Cumberland Valley Retina Consultants
RECRUITING
Hagerstown
Michigan
Associated Retinal Consultants - Royal Oak
RECRUITING
Royal Oak
Minnesota
Retina Consultants Minnesota
RECRUITING
Saint Louis Park
North Carolina
Western Carolina Retinal Associate PA
RECRUITING
Asheville
Duke University Medical Center
RECRUITING
Durham
Graystone Eye
RECRUITING
Hickory
North Carolina (NC) Retina Associates - Wake Forest Office
RECRUITING
Wake Forest
Piedmont Retina Specialists
RECRUITING
Winston-salem
New York
Long Island Vitreoretinal Consultants;Opthalmology
RECRUITING
Hauppauge
Retina Vitreous Surgeons of CNY PC
RECRUITING
Liverpool
Ohio
Cincinnati Eye Institute
RECRUITING
Blue Ash
Ohio State Eye and Ear Institute
RECRUITING
Columbus
Oklahoma
Tulsa Retina Consultants
RECRUITING
Tulsa
Oregon
Cascade Medical Research Institute LLC
RECRUITING
Springfield
Pennsylvania
Erie Retina Research
RECRUITING
Erie
Wills Eye Hospital
RECRUITING
Philadelphia
Sewickely Eye Group
RECRUITING
Sewickley
South Carolina
Palmetto Retina Center
RECRUITING
West Columbia
Tennessee
Charles Retina Institute
RECRUITING
Germantown
Texas
Retina Research Institute of Texas
RECRUITING
Abilene
Texas Retina Associates
RECRUITING
Arlington
Austin Clinical Research LLC
RECRUITING
Austin
Austin Retina Associates
RECRUITING
Austin
Retina & Vitreous of Texas
RECRUITING
Bellaire
Texas Retina Associates
RECRUITING
Dallas
Valley Retina Institute P.A.
RECRUITING
Mcallen
Brown Retina Institute
RECRUITING
San Antonio
Medical Center Ophthalmology Associates
RECRUITING
San Antonio
Retina Consultants of Texas - San Antonio
RECRUITING
San Antonio
Retina Consultants of Texas
RECRUITING
The Woodlands
Strategic Clinical Research Group, LLC
RECRUITING
Willow Park
Utah
Retina Associates of Utah, PLLC;Clinical Research
RECRUITING
Salt Lake City
Virginia
Piedmont Eye Center
RECRUITING
Lynchburg
Wagner Kapoor Institute
RECRUITING
Norfolk
Retina Institute of Virginia
RECRUITING
Richmond
Virginia Eye Institute - Richmond - 7301 Forest Ave
RECRUITING
Richmond
Washington
Spokane Eye Clinical Research
RECRUITING
Spokane
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Shanghai General Hospital - North Campus
RECRUITING
Shanghai
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Eye Hospital,WMU(Zhejiang Eye Hospital)
RECRUITING
Wenzhou
Puerto Rico
Emanuelli Research and Development Center LLC
RECRUITING
Arecibo
Contact Information
Primary
Reference Study ID Number: GR43828 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date: 2022-06-22
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 546
Treatments
Experimental: Part 1: Single Ascending Dose (SAD) Stage
Participants received a single dose of RO7446603 at five different dose levels as IVT injection on Day 1.
Experimental: Part 2: Multiple Dose (MD) Monotherapy Stage
Participants received four different dose levels of RO7446603 (two doses at each planned dose level) as IVT injection, every 8 weeks (Q8W).
Experimental: Part 3: MD Co-administration With Aflibercept Stage
Participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W along with four doses of aflibercept IVT injections, every 4 weeks (Q4W).
Experimental: Part 4: MD Co-administration With Faricimab Stage
Participants received a single dose of faricimab followed by a 4-week enrichment screening period. Eligible participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W, along with three doses of faricimab (co-administered with RO7446603 or alone) as IVT injection, Q4W.
Experimental: Part 5: MD Co-mixed With Faricimab Stage
Participants will receive two different dose levels of RO7446603 (co-mixed with faricimab or faricimab alone) as IVT injection, Q4W for the first six doses followed by Q8W for four doses.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.