RECRUITING

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME

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Conditions

Diabetic Macular EdemaPort Delivery System

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2019-09-30
Study Completion:2027-11-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04108156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years at time of signing informed consent form (ICF)
  2. * Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
  3. * Glycated haemoglobin (HbA1c) level of ≤10% within 2 months prior to screening or at screening
  4. * Macular thickening secondary to DME involving the center of the fovea with CST ≥325 micrometer (µm) on SD-OCT at screening
  5. * BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)
  1. * High-risk PDR
  2. * Active intraocular inflammation (grade trace or above)
  3. * Suspected or active ocular or periocular infection of either eye
  4. * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
  5. * Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
  6. * Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
  7. * Uncontrolled blood pressure

Contacts and Locations

Study Contact

Reference Study ID Number: GR40550 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206
United States
Retinal Consultants of Arizona;Opthalmology
Phoenix, Arizona, 85014
United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85016
United States
Associated Retina Consultants
Phoenix, Arizona, 85020
United States
California Retina Consultants
Bakersfield, California, 93309
United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
United States
The Retina Partners
Encino, California, 91436
United States
Retina Consultants of Orange County;Clinical Research
Fullerton, California, 92835
United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, 90095
United States
Northern California Retina-Vitreous Associates
Mountain View, California, 94040
United States
East Bay Retina Consultants
Oakland, California, 94609
United States
Doheny Eye Institute
Pasadena, California, 91105
United States
California Eye Specialists Medical Group
Pasadena, California, 91107
United States
Retina Consultants Medical Group
Sacramento, California, 95841
United States
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
United States
Orange County Retina Medical Group
Santa Ana, California, 92705
United States
California Retina Consultants;Research Department
Santa Barbara, California, 93103
United States
Eye Center of Northern Colorado
Fort Collins, Colorado, 80528
United States
Colorado Clinical Research
Lakewood, Colorado, 80228
United States
Retina Group of New England
Waterford, Connecticut, 06385
United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
Retina Specialty Institute
Pensacola, Florida, 32503
United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324
United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
United States
Southern Vitreoretinal Associates;Research
Tallahassee, Florida, 32308
United States
Retina Associates of Florida;Retina Associates of Florida
Tampa, Florida, 33609
United States
Southeast Retina Center
Augusta, Georgia, 30909
United States
Georgia Retina
Marietta, Georgia, 30060
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Illinois Retina Associates
Joliet, Illinois, 60435
United States
University Retina
Lemont, Illinois, 60439
United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
United States
Retina Associates
Lenexa, Kansas, 66215
United States
Retina & Vitreous Associates of Kentucky
Lexington, Kentucky, 40509
United States
Maine Eye Center
Portland, Maine, 04605
United States
The Retina Care Center
Baltimore, Maryland, 21209
United States
Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst
Baltimore, Maryland, 21287
United States
The Retina Group of Washington;Retinal Disease
Chevy Chase, Maryland, 20815
United States
Cumberland Valley Retina Consultants;Clinical Research
Hagerstown, Maryland, 21740
United States
Retina Specialist
Towson, Maryland, 21204
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
United States
Vitreo Retinal Associates
Worcester, Massachusetts, 01605
United States
Retina Specialists Of Michigan
Grand Rapids, Michigan, 49546
United States
Associated Retinal Consultants - Royal Oak
Royal Oak, Michigan, 48073
United States
VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435
United States
Pepose Vision Institute
Chesterfield, Missouri, 63017
United States
Retina Institute
St Louis, Missouri, 63128
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
United States
Retina Associates of New Jersey
Teaneck, New Jersey, 07666
United States
Long Island Vitreoretinal Consultants;Opthalmology
Great Neck, New York, 11021
United States
Retina Vitreous Surgeons of Central New York
Liverpool, New York, 13088
United States
New York University (NYU)
New York, New York, 10012
United States
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572
United States
Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research
Asheville, North Carolina, 28803
United States
Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina
Charlotte, North Carolina, 28210
United States
Duke Eye Center
Durham, North Carolina, 27705
United States
Graystone Eye;Clinical Research
Hickory, North Carolina, 28602
United States
Cape Fear Retinal Associates
Wilmington, North Carolina, 28401
United States
Cincinnati Eye Institute;Retina
Cincinnati, Ohio, 45242
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Ohio State Havener Eye Institute;Ophthalmology Research
Columbus, Ohio, 43212
United States
Midwest Retina;Retina/Vitreous
Dublin, Ohio, 43016
United States
Retina Vitreous Center - Glen Eagles
Edmond, Oklahoma, 73013
United States
Retina Northwest;Research Department
Portland, Oregon, 97221
United States
Cumberland Valley Retina Consultants
Chambersburg, Pennsylvania, 17201
United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
United States
Charleston Neuroscience
Ladson, South Carolina, 29456
United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
United States
Palmetto Retina Center
West Columbia, South Carolina, 29169
United States
Palmetto Retina Center
West Columbia, South Carolina, 29169
United States
Charles Retina Institution;Retina surgery
Germantown, Tennessee, 38138
United States
Tennessee Retina
Nashville, Tennessee, 37203
United States
Retina Research Institute of Texas
Abilene, Texas, 79606
United States
Texas Retina Associates
Arlington, Texas, 76012
United States
Austin Research Center for Retina
Austin, Texas, 78705
United States
Austin Retina Associates;Opthalmology
Austin, Texas, 78705
United States
Austin Clinical Research, LLC
Austin, Texas, 78750
United States
Retina & Vitreous of Texas
Bellaire, Texas, 77401
United States
Texas Retina Associates;Research
Dallas, Texas, 75231
United States
Texas Retina Associates
Fort Worth, Texas, 76104
United States
Retina Consultants of Texas
Houston, Texas, 77401
United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
United States
Rocky Mountain Retina Consultants
Murray, Utah, 84107
United States
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah, 84107
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States
Wagner Kapoor Institute;Opthalmology
Norfolk, Virginia, 23502
United States
Retina Institute of Virginia
Richmond, Virginia, 23235
United States
Pacific Northwest Retina
Silverdale, Washington, 98383
United States
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-30
Study Completion Date2027-11-16

Study Record Updates

Study Start Date2019-09-30
Study Completion Date2027-11-16

Terms related to this study

Keywords Provided by Researchers

  • Port Delivery System

Additional Relevant MeSH Terms

  • Diabetic Macular Edema