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Active (not recruiting) Phase 1 NCT06847854

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

Phase 1 – testing safety in a small group of people
Conditions: Diabetic Macular Edema

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association * 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 major illness or major surgical procedure ≤ 4 weeks before Day 1 * 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
Interventions
RO7497372
DRUG
Locations 38
Puerto Rico (1)
Emanuelli Research and Development Center
Arecibo
United States (37)
Austin Clinical Research LLC
Austin , Texas
Ross Eye Institute
Buffalo , New York
Cleveland Clinic
Cleveland , Ohio
Erie Retinal Surgery
Erie , Pennsylvania
Verum Research LLC
Eugene , Oregon
Retina Group of Washington
Fairfax , Virginia
Emerson Clinical Research Institute
Falls Church , Virginia
Charles Retina Institute
Germantown , Tennessee
Global Research Management
Glendale , California
Retina Associates of Michigan
Grand Blanc , Michigan
Foundation for Vision Research
Grand Rapids , Michigan
Cumberland Valley Retina PC
Hagerstown , Maryland
Arkansas Retina Research
Little Rock , Arkansas
Piedmont Eye Center
Lynchburg , Virginia
Mississippi Retina Associates
Madison , Mississippi
Florida Eye Associates
Melbourne , Florida
Barnet Dulaney Perkins Eye Center
Mesa , Arizona
Medeye Associates
Miami , Florida
Retinal Consultants Medical Group
Modesto , California
Carolina Eyecare Physicians
Mt. Pleasant , South Carolina
Retina Associates of NY
New York , New York
Wagner Kapoor Institute
Norfolk , Virginia
Retinal Consultants of AZ, Ltd
Peoria , Arizona
Mid Atlantic Retina
Philadelphia , Pennsylvania
Associated Retina Consultants
Phoenix , Arizona
EyeHealth Northwest
Portland , Oregon
Sierra Eye Associates
Reno , Nevada
Retina Consultants Minnesota
Saint Louis Park , Minnesota
Brown Retina Institute
Schertz , Texas
Spokane Eye Clinical Research
Spokane , Washington
The Retina Institute
St Louis , Missouri
East Florida Eye Institute
Stuart , Florida
Retina Consultants of Texas
The Woodlands , Texas
Bay Area Retina Associates
Walnut Creek , California
Retina Specialists of Tampa
Wesley Chapel , Florida
Salt Lake Retina
West Jordan , Utah
Center for Retina and Macula Disease
Winter Haven , Florida
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
08.12.2022
Completion date
12.01.2027
Registry ID
NCT06847854
Source
clinicaltrials.gov
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