A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
NCT ID: NCT06847854
Last Updated: 2025-12-24
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
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RECRUITING
PHASE1
176 participants
INTERVENTIONAL
2022-12-08
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part 2: RO7497372 High Dose
Participants will receive 6 doses of RO7497372, high dose, Q4W followed by 3 doses, Q8W as an IVT injection up to Week 44 in the study eye.
RO7497372
RO7497372 will be administered as IVT injection as per the schedule specified in the arms.
Part 1: Multiple Ascending Dose
Participants will receive multiple ascending doses of RO7497372, 3 times every 4 weeks (Q4W) as an IVT injection up to Week 8 in the study eye.
RO7497372
RO7497372 will be administered as IVT injection as per the schedule specified in the arms.
Part 2: RO7497372 Low Dose
Participants will receive 6 doses of RO7497372, low dose, Q4W followed by 3 doses, every eight weeks (Q8W) as an IVT injection up to Week 44 in the study eye.
RO7497372
RO7497372 will be administered as IVT injection as per the schedule specified in the arms.
Interventions
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RO7497372
RO7497372 will be administered as IVT injection as per the schedule specified in the arms.
Eligibility Criteria
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Inclusion Criteria
* Participant consents to AH collection
* Collection of \> 90 microlitres (µL) AH (at each visit required per schedule of activities \[SoA\]) if deemed feasible and safe by the Investigator.
* Macular thickening secondary to DME involving the center of the fovea with CST \>= 325 µm at screening
* Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive) at screening
* Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
* Diagnosis of non-proliferative DR
* Treatment-naive and Pre-treated participants after washout
Exclusion Criteria
* Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
* Active cancer ≤ 1 year prior to Day 1
* Cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to Day 1
* HbA1c ≥ 12% at screening
* Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
* History of vitreoretinal surgery/pars plana vitrectomy
* Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
* History of any glaucoma surgery including laser glaucoma procedures
* Uncontrolled glaucoma
* Any active intra- or periocular infection on Day 1
* Any active or history of Intraocular inflammation
* Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
* Any proliferative DR
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Central Contacts
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Reference Study ID Number: BP44175 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
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BP44175
Identifier Type: -
Identifier Source: org_study_id