A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
NCT ID: NCT06850922
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
546 participants
INTERVENTIONAL
2022-06-22
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
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).
RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
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).
RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Aflibercept
Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm.
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.
RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Faricimab
Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.
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.
RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Faricimab
Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Aflibercept
Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm.
Faricimab
Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Uncontrolled blood pressure (BP)
* Pregnancy or breastfeeding, or intention to become pregnant during the study
* For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5: IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatment prior to Day 1 for treatment naïve participants
* Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1
* Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior to Day 1
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
* Proliferative diabetic retinopathy (PDR) in the study eye
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Associated Retinal Consultants PC
Phoenix, Arizona, United States
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retinal Diagnostic Center
Campbell, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Retinal Consultants Medical Group
Modesto, California, United States
Northern California Retina-Vitreous Associates
Mountain View, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Macula Retina Vitreous Research Institute
Torrance, California, United States
University of Colorado - Eye Center - PPDS
Aurora, Colorado, United States
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, United States
Retina Specialists of Colorado
Denver, Colorado, United States
Advanced Vision Research Institute
Longmont, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Blue Ocean Clinical Research
Clearwater, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Retina Institute
Jacksonville, Florida, United States
Retina Associates of Florida;Retina Associates of Florida
Tampa, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina PC
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
Illinois Eye and Ear Infirmary
Chicago, Illinois, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Raj K. Maturi, MD PC
Indianapolis, Indiana, United States
The Retina Care Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Associated Retinal Consultants - Royal Oak
Royal Oak, Michigan, United States
Retina Consultants Minnesota
Saint Louis Park, Minnesota, United States
Long Island Vitreoretinal Consultants;Opthalmology
Hauppauge, New York, United States
Retina Vitreous Surgeons of CNY PC
Liverpool, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Graystone Eye
Hickory, North Carolina, United States
North Carolina (NC) Retina Associates - Wake Forest Office
Wake Forest, North Carolina, United States
Piedmont Retina Specialists
Winston-Salem, North Carolina, United States
Cincinnati Eye Institute
Blue Ash, Ohio, United States
Ohio State Eye and Ear Institute
Columbus, Ohio, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, United States
Cascade Medical Research Institute LLC
Springfield, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Sewickely Eye Group
Sewickley, Pennsylvania, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Charles Retina Institute
Germantown, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina & Vitreous of Texas
Bellaire, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Valley Retina Institute P.A.
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States
Brown Retina Institute
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Institute
Norfolk, Virginia, United States
Virginia Eye Institute - Richmond - 7301 Forest Ave
Richmond, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Eye Hospital,WMU(Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
Beijing Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Shanghai General Hospital - North Campus
Shanghai, , China
Emanuelli Research and Development Center LLC
Arecibo, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: GR43828 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S.)
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISRCTN14152148
Identifier Type: REGISTRY
Identifier Source: secondary_id
GR43828
Identifier Type: -
Identifier Source: org_study_id