A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
NCT ID: NCT04503551
Last Updated: 2025-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
174 participants
INTERVENTIONAL
2020-08-10
2026-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
NCT03677934
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
NCT02510794
Extension Study for the Port Delivery System With Ranibizumab (Portal)
NCT03683251
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
NCT04108156
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
NCT06847542
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PDS Arm
Participants randomized to the PDS arm will receive two intravitreal ranibizumab injections 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 every 36-weeks (Q36W) thereafter
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.
Comparator Arm
Participants randomized to the comparator arm will undergo study visits every 4 weeks (Q4W) for comprehensive clinical monitoring until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q36W thereafter. Participants will be eligible to receive intravitreal ranibizumab 0.5 mg injections if treatment eligibility criteria are met.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
* HbA1c level of ≤12% within 2 months prior to screening or at screening
* Moderately severe or severe NPDR (ETDRS-DRSS level 47 or 53)
* BCVA score of ≥ 69 letters (20/40 approximate Snellen equivalent or better)
Exclusion Criteria
* Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
* Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
* Current systemic treatment for a confirmed active systemic infection
* Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
* History 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 patient at high risk for treatment complications in the opinion of the investigator or Sponsor
* Presence of center-involved diabetic macular edema (defined as CST ≥325 µm)
* Any intravitreal anti-VEGF treatment at any time prior to randomization
* Any use of medicated intraocular implants, including Ozurdex® or Iluvien® implants at any time prior to randomization
* Any intravitreal corticosteroid treatment at any time prior to randomization
* Any periocular (e.g., subtenon) corticosteroid treatment at any time prior to randomization
* Any PRP at any time prior to randomization
* Any macular laser photocoagulation (such as micropulse and focal or grid laser) at any time prior to randomization
* Active intraocular inflammation (grade trace or above)
* Clinically significant abnormalities of the vitreous-retinal interface involving the macular area or disrupting the macular architecture, such as vitreous-retinal traction or epiretinal membrane (assessed by the investigator and confirmed by the central reading center)
* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* Any concurrent ocular condition (e.g., cataract, epiretinal membrane) that would require surgical intervention during the study to prevent or treat visual loss that might result from that condition
* Any concurrent ocular condition (e.g., amblyopia, strabismus) that may affect interpretation of study results
* History of other ocular diseases that gives reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of study results, or that renders the participant at high risk for treatment complications
* Suspected or active ocular or periocular infection of either eye
* Any history uveitis including idiopathic, drug-associated or autoimmune-associated uveitis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
Retinal Consultants of Arizona;Opthalmology
Phoenix, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
California Retina Consultants
Bakersfield, 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
California Eye Specialists Medical Group
Pasadena, California, United States
Kaiser Permanente;RESEARCH AND EVALUATION
Riverside, California, United States
Retina Consultants Medical Group
Sacramento, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
Southwest Retina Research Center
Durango, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Retina Specialty Institute
Pensacola, Florida, United States
Fort Lauderdale Eye Institute
Plantation, 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
Retina Consultants of Hawaii at Pali Momi Medical Center
‘Aiea, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Illinois Retina Associates
Joliet, Illinois, United States
University Retina
Lemont, Illinois, United States
Retina Associates
Lenexa, Kansas, 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
Cumberland Valley Retina Consultants;Clinical Research
Hagerstown, Maryland, 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
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
Retina Vitreous Surgeons of Central New York
Liverpool, New York, United States
New York University (NYU)
New York, 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
Cape Fear Retinal Associates
Wilmington, North Carolina, United States
Ohio State Havener Eye Institute;Ophthalmology Research
Columbus, Ohio, United States
Retina Vitreous Center - Glen Eagles
Edmond, Oklahoma, United States
Retina Northwest;Research Department
Portland, Oregon, United States
Mid Atlantic Retina;Retina Research
Philadelphia, Pennsylvania, United States
Charleston Neuroscience
Ladson, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Charles Retina Institution;Retina surgery
Germantown, Tennessee, United States
Southeastern Retina Associates
Knoxville, Tennessee, United States
Tennessee Retina
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Retina Associates;Opthalmology
Austin, Texas, United States
Retina & Vitreous of Texas
Bellaire, Texas, United States
Texas Retina Associates;Research
Dallas, Texas, United States
Retina Center of Texas
Grapevine, 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
Emanuelli Research & Development Center
Arecibo, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pieramici DJ, Awh CC, Chang M, Emanuelli A, Holekamp NM, Hu AY, Suner IJ, Wykoff CC, Brittain C, Howard D, Quezada-Ruiz C, Santhanakrishnan A, Latkany P. Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema: The Pavilion Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):317-325. doi: 10.1001/jamaophthalmol.2025.0001.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GR41675
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.