A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)
Who is this study for? Patients with Diabetic Macular Edema
Status: Recruiting
Location: See all (92) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years at time of signing informed consent form (ICF)
• Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
• Glycated haemoglobin (HbA1c) level of ≤10% within 2 months prior to screening or at screening
⁃ Study eye
• Macular thickening secondary to DME involving the center of the fovea with CST ≥325 micrometer (µm) on SD-OCT at screening
• BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)
• Having experienced a septum dislodgement in the original implant while in the main study or after exiting the main study
• Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center
Locations
United States
Arizona
Barnet Dulaney Perkins Eye Center
ACTIVE_NOT_RECRUITING
Mesa
Arizona Retina and Vitreous Consultants
COMPLETED
Phoenix
Associated Retina Consultants
COMPLETED
Phoenix
Retinal Consultants of Arizona;Opthalmology
COMPLETED
Phoenix
California
California Retina Consultants
RECRUITING
Bakersfield
Retina-Vitreous Associates Medical Group
COMPLETED
Beverly Hills
The Retina Partners
COMPLETED
Encino
Retina Consultants of Orange County;Clinical Research
RECRUITING
Fullerton
Jules Stein Eye Institute/ UCLA
COMPLETED
Los Angeles
Northern California Retina-Vitreous Associates
COMPLETED
Mountain View
East Bay Retina Consultants
RECRUITING
Oakland
California Eye Specialists Medical Group
ACTIVE_NOT_RECRUITING
Pasadena
Doheny Eye Institute
COMPLETED
Pasadena
Retina Consultants Medical Group
RECRUITING
Sacramento
Zuckerberg San Francisco General Hospital and Trauma Center
COMPLETED
San Francisco
Orange County Retina Medical Group
RECRUITING
Santa Ana
California Retina Consultants;Research Department
COMPLETED
Santa Barbara
Colorado
Eye Center of Northern Colorado
ACTIVE_NOT_RECRUITING
Fort Collins
Colorado Clinical Research
COMPLETED
Lakewood
Connecticut
Retina Group of New England
ACTIVE_NOT_RECRUITING
Waterford
Florida
Retina Group of Florida
ACTIVE_NOT_RECRUITING
Fort Lauderdale
National Ophthalmic Research Institute
COMPLETED
Fort Myers
Retina Specialty Institute
RECRUITING
Pensacola
Fort Lauderdale Eye Institute
RECRUITING
Plantation
Retina Vitreous Associates of Florida
RECRUITING
St. Petersburg
Southern Vitreoretinal Associates;Research
WITHDRAWN
Tallahassee
Retina Associates of Florida;Retina Associates of Florida
COMPLETED
Tampa
Georgia
Southeast Retina Center
RECRUITING
Augusta
Georgia Retina
COMPLETED
Marietta
Iowa
Wolfe Eye Clinic
COMPLETED
West Des Moines
Illinois
Northwestern Memorial Hospital
COMPLETED
Chicago
Illinois Retina Associates
COMPLETED
Joliet
University Retina
COMPLETED
Lemont
Kansas
Retina Associates
COMPLETED
Lenexa
Kentucky
Retina & Vitreous Associates of Kentucky
COMPLETED
Lexington
Massachusetts
Ophthalmic Consultants of Boston
COMPLETED
Boston
Tufts Medical Center
ACTIVE_NOT_RECRUITING
Boston
Vitreo Retinal Associates
COMPLETED
Worcester
Maryland
Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst
COMPLETED
Baltimore
The Retina Care Center
ACTIVE_NOT_RECRUITING
Baltimore
The Retina Group of Washington;Retinal Disease
RECRUITING
Chevy Chase
Cumberland Valley Retina Consultants;Clinical Research
RECRUITING
Hagerstown
Retina Specialist
COMPLETED
Towson
Maine
Maine Eye Center
ACTIVE_NOT_RECRUITING
Portland
Michigan
Retina Specialists Of Michigan
COMPLETED
Grand Rapids
Associated Retinal Consultants - Royal Oak
COMPLETED
Royal Oak
Minnesota
VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota
COMPLETED
Minneapolis
Missouri
Pepose Vision Institute
COMPLETED
Chesterfield
Retina Institute
COMPLETED
St Louis
North Carolina
Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research
ACTIVE_NOT_RECRUITING
Asheville
Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina
COMPLETED
Charlotte
Duke Eye Center
COMPLETED
Durham
Graystone Eye;Clinical Research
COMPLETED
Hickory
Cape Fear Retinal Associates
WITHDRAWN
Wilmington
New Jersey
Envision Ocular, LLC
COMPLETED
Bloomfield
Retina Associates of New Jersey
ACTIVE_NOT_RECRUITING
Teaneck
Nevada
Sierra Eye Associates
RECRUITING
Reno
New York
Long Island Vitreoretinal Consultants;Opthalmology
COMPLETED
Great Neck
Retina Vitreous Surgeons of Central New York
WITHDRAWN
Liverpool
New York University (NYU)
COMPLETED
New York
Ophthalmic Consultants of Long Island
COMPLETED
Oceanside
Ohio
Cincinnati Eye Institute;Retina
RECRUITING
Cincinnati
Cleveland Clinic
COMPLETED
Cleveland
Ohio State Havener Eye Institute;Ophthalmology Research
RECRUITING
Columbus
Midwest Retina;Retina/Vitreous
COMPLETED
Dublin
Oklahoma
Retina Vitreous Center - Glen Eagles
COMPLETED
Edmond
Oregon
Retina Northwest;Research Department
COMPLETED
Portland
Pennsylvania
Cumberland Valley Retina Consultants
WITHDRAWN
Chambersburg
Mid Atlantic Retina
COMPLETED
Philadelphia
South Carolina
Charleston Neuroscience
COMPLETED
Ladson
Carolina Eyecare Physicians
COMPLETED
Mt. Pleasant
Palmetto Retina Center
COMPLETED
West Columbia
Palmetto Retina Center
WITHDRAWN
West Columbia
Tennessee
Charles Retina Institution;Retina surgery
WITHDRAWN
Germantown
Tennessee Retina
ACTIVE_NOT_RECRUITING
Nashville
Texas
Retina Research Institute of Texas
COMPLETED
Abilene
Texas Retina Associates
COMPLETED
Arlington
Austin Clinical Research, LLC
COMPLETED
Austin
Austin Research Center for Retina
COMPLETED
Austin
Austin Retina Associates;Opthalmology
COMPLETED
Austin
Retina & Vitreous of Texas
WITHDRAWN
Bellaire
Texas Retina Associates;Research
ACTIVE_NOT_RECRUITING
Dallas
Texas Retina Associates
COMPLETED
Fort Worth
Retina Consultants of Texas
RECRUITING
Houston
Medical Center Ophthalmology Associates
RECRUITING
San Antonio
Utah
Rocky Mountain Retina Consultants
COMPLETED
Murray
Retina Associates of Utah, PLLC;Clinical Research
COMPLETED
Salt Lake City
Virginia
Piedmont Eye Center
COMPLETED
Lynchburg
Wagner Kapoor Institute;Opthalmology
ACTIVE_NOT_RECRUITING
Norfolk
Retina Institute of Virginia
RECRUITING
Richmond
Washington
Pacific Northwest Retina
COMPLETED
Silverdale
Spokane Eye Clinical Research;Spokane Eye Surgery Center
RECRUITING
Spokane
Contact Information
Primary
Reference Study ID Number: GR40550 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2019-09-30
Estimated Completion Date: 2027-11-16
Participants
Target number of participants: 634
Treatments
Experimental: PDS Arm
Participants randomized to the PDS arm will receive IVT ranibizumab injection Q4W (loading phase) and will then have the PDS implant (pre-filled with ranibizumab) surgically inserted. PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.
Active_comparator: Intravitreal Arm
Participants randomized to the intravitreal arm will receive IVT ranibizumab injection Q4W until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.
Experimental: Substudy: Cohort 1
Participants will undergo re-implantation with the updated PDS implant (pre-filled with ranibizumab 100 milligrams per milliliter \[mg/mL\]) on Day 1 (or enrollment visit) and then will have two refill-exchanges (ranibizumab 100 mg/mL) Q24W up to 48 weeks.
Experimental: Substudy: Cohort 2a
Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no scheduled refill-exchange visit in the main study, will undergo two refill-exchange procedures (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.
Experimental: Substudy: Cohort 2b
Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, regardless of whether the refill exchange was administered or the visit was missed, will undergo one refill-exchange procedure (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche