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
NCT ID: NCT04108156
Last Updated: 2026-01-09
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
PHASE3
634 participants
INTERVENTIONAL
2019-09-30
2027-11-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
Ranibizumab refill exchange
Will be administered as per the schedule described in individual arm.
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.
Intravitreal Ranibizumab 0.5 mg Injection
Will be administered as per the schedule described in individual arm.
Ranibizumab refill exchange
Will be administered as per the schedule described in individual arm.
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.
PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
Ranibizumab refill exchange
Will be administered as per the schedule described in individual arm.
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.
Ranibizumab refill exchange
Will be administered as per the schedule described in individual arm.
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.
Ranibizumab refill exchange
Will be administered as per the schedule described in individual arm.
Interventions
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PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
Intravitreal Ranibizumab 0.5 mg Injection
Will be administered as per the schedule described in individual arm.
Ranibizumab refill exchange
Will be administered as per the schedule described in individual arm.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Active intraocular inflammation (grade trace or above)
* Suspected or active ocular or periocular infection of either eye
* 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
* Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
* Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
* Uncontrolled blood pressure
Substudy:
* Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications
* Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
* Current systemic treatment for a confirmed active systemic infection
* Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in Study GR40550) within 6 months prior to enrollment
* Use of antimitotic or antimetabolite therapy within 30 days
* Any ocular condition that may render the participant at high risk for surgical or treatment complications
* Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
* Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
* Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
* Concurrent conjunctival, tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
* Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis)
* Any history of uveitis
* Active blepharitis
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
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 Arizona;Opthalmology
Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County;Clinical Research
Fullerton, California, United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States
Northern California Retina-Vitreous Associates
Mountain View, California, United States
East Bay Retina Consultants
Oakland, California, United States
Doheny Eye Institute
Pasadena, California, United States
California Eye Specialists Medical Group
Pasadena, California, United States
Retina Consultants Medical Group
Sacramento, California, United States
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
California Retina Consultants;Research Department
Santa Barbara, California, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Fort Lauderdale Eye Institute
Plantation, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Southern Vitreoretinal Associates;Research
Tallahassee, Florida, United States
Retina Associates of Florida;Retina Associates of Florida
Tampa, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina
Marietta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Illinois Retina Associates
Joliet, Illinois, United States
University Retina
Lemont, Illinois, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates
Lenexa, Kansas, United States
Retina & Vitreous Associates of Kentucky
Lexington, Kentucky, United States
Maine Eye Center
Portland, Maine, United States
The Retina Care Center
Baltimore, Maryland, United States
Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst
Baltimore, Maryland, United States
The Retina Group of Washington;Retinal Disease
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants;Clinical Research
Hagerstown, Maryland, United States
Retina Specialist
Towson, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Vitreo Retinal Associates
Worcester, Massachusetts, United States
Retina Specialists Of Michigan
Grand Rapids, Michigan, United States
Associated Retinal Consultants - Royal Oak
Royal Oak, Michigan, United States
VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota
Minneapolis, Minnesota, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Retina Associates of New Jersey
Teaneck, New Jersey, United States
Long Island Vitreoretinal Consultants;Opthalmology
Great Neck, New York, United States
Retina Vitreous Surgeons of Central New York
Liverpool, New York, United States
New York University (NYU)
New York, New York, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, United States
Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research
Asheville, North Carolina, United States
Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina
Charlotte, North Carolina, United States
Duke Eye Center
Durham, North Carolina, United States
Graystone Eye;Clinical Research
Hickory, North Carolina, United States
Cape Fear Retinal Associates
Wilmington, North Carolina, United States
Cincinnati Eye Institute;Retina
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State Havener Eye Institute;Ophthalmology Research
Columbus, Ohio, United States
Midwest Retina;Retina/Vitreous
Dublin, Ohio, United States
Retina Vitreous Center - Glen Eagles
Edmond, Oklahoma, United States
Retina Northwest;Research Department
Portland, Oregon, United States
Cumberland Valley Retina Consultants
Chambersburg, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Charleston Neuroscience
Ladson, South Carolina, United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Charles Retina Institution;Retina surgery
Germantown, Tennessee, United States
Tennessee Retina
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates;Opthalmology
Austin, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina & Vitreous of Texas
Bellaire, Texas, United States
Texas Retina Associates;Research
Dallas, Texas, United States
Texas Retina Associates
Fort Worth, Texas, United States
Retina Consultants of Texas
Houston, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Rocky Mountain Retina Consultants
Murray, Utah, United States
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Institute;Opthalmology
Norfolk, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Pacific Northwest Retina
Silverdale, Washington, United States
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, United States
Countries
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Central Contacts
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Reference Study ID Number: GR40550 https://forpatients.roche.com/
Role: CONTACT
References
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Khanani AM, Campochiaro PA, Graff JM, Marcus DM, Miller D, Mittra RA, Regillo C, Sheth VS, Bobbala A, Gune S, Lin S, Quezada-Ruiz C, Malhotra V. Continuous Ranibizumab via Port Delivery System vs Monthly Ranibizumab for Treatment of Diabetic Macular Edema: The Pagoda Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):326-335. doi: 10.1001/jamaophthalmol.2025.0006.
Stockwell AD, Chang MC, Mahajan A, Forrest W, Anegondi N, Pendergrass RK, Selvaraj S, Reeder J, Wei E, Iglesias VA, Creps NM, Macri L, Neeranjan AN, van der Brug MP, Scales SJ, McCarthy MI, Yaspan BL. Multi-ancestry GWAS analysis identifies two novel loci associated with diabetic eye disease and highlights APOL1 as a high risk locus in patients with diabetic macular edema. PLoS Genet. 2023 Aug 16;19(8):e1010609. doi: 10.1371/journal.pgen.1010609. eCollection 2023 Aug.
Other Identifiers
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GR40550
Identifier Type: -
Identifier Source: org_study_id
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