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)
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Retina Research
RECRUITING
Little Rock
Arizona
Barnet Dulaney Perkins Eye Center
WITHDRAWN
Mesa
Retinal Consultants of AZ, Ltd
RECRUITING
Peoria
Associated Retina Consultants
RECRUITING
Phoenix
California
Global Research Management
RECRUITING
Glendale
Retinal Consultants Medical Group
RECRUITING
Modesto
Bay Area Retina Associates
ACTIVE_NOT_RECRUITING
Walnut Creek
Florida
Florida Eye Associates
RECRUITING
Melbourne
Medeye Associates
ACTIVE_NOT_RECRUITING
Miami
East Florida Eye Institute
RECRUITING
Stuart
Retina Specialists of Tampa
RECRUITING
Wesley Chapel
Center for Retina and Macula Disease
ACTIVE_NOT_RECRUITING
Winter Haven
Maryland
Cumberland Valley Retina PC
RECRUITING
Hagerstown
Michigan
Retina Associates of Michigan
RECRUITING
Grand Blanc
Foundation for Vision Research
COMPLETED
Grand Rapids
Minnesota
Retina Consultants Minnesota
ACTIVE_NOT_RECRUITING
Saint Louis Park
Missouri
The Retina Institute
ACTIVE_NOT_RECRUITING
St Louis
Mississippi
Mississippi Retina Associates
RECRUITING
Madison
New York
Ross Eye Institute
RECRUITING
Buffalo
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Oregon
Verum Research LLC
RECRUITING
Eugene
EyeHealth Northwest
RECRUITING
Portland
Pennsylvania
Erie Retinal Surgery
ACTIVE_NOT_RECRUITING
Erie
Mid Atlantic Retina
ACTIVE_NOT_RECRUITING
Philadelphia
South Carolina
Carolina Eyecare Physicians
RECRUITING
Mt. Pleasant
Tennessee
Charles Retina Institute
RECRUITING
Germantown
Texas
Austin Clinical Research LLC
ACTIVE_NOT_RECRUITING
Austin
Brown Retina Institute
ACTIVE_NOT_RECRUITING
Schertz
Retina Consultants of Texas
RECRUITING
The Woodlands
Utah
Salt Lake Retina
RECRUITING
West Jordan
Virginia
Retina Group of Washington
RECRUITING
Fairfax
Emerson Clinical Research Institute
RECRUITING
Falls Church
Piedmont Eye Center
RECRUITING
Lynchburg
Washington
Spokane Eye Clinical Research
RECRUITING
Spokane
Other Locations
Puerto Rico
Emanuelli Research and Development Center
RECRUITING
Arecibo
Contact Information
Primary
Reference Study ID Number: BP44175 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date:2022-12-08
Estimated Completion Date:2027-05-30
Participants
Target number of participants:176
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.