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
Public ClinicalTrials.gov record NCT04108156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04108156
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 672 participants
Conditions and interventions
Conditions
Interventions
- PDS Implant Pre-Filled with 100 mg/mL Ranibizumab Drug
- Intravitreal Ranibizumab 0.5 mg Injection Drug
- Ranibizumab refill exchange Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2019 (Actual)
- Primary completion
- Jul 20, 2027 (Estimated)
- Completion
- Jul 20, 2027 (Estimated)
- Last update posted
- Oct 8, 2026
2019 – 2027
United States locations
- U.S. sites
- 89
- U.S. states
- 30
- U.S. cities
- 82
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Mesa | Arizona | 85206 | — |
| Retinal Consultants of Arizona;Opthalmology | Phoenix | Arizona | 85014 | — |
| Arizona Retina and Vitreous Consultants | Phoenix | Arizona | 85016 | — |
| Associated Retina Consultants | Phoenix | Arizona | 85020 | — |
| California Retina Consultants | Bakersfield | California | 93309 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| The Retina Partners | Encino | California | 91436 | — |
| Retina Consultants of Orange County;Clinical Research | Fullerton | California | 92835 | — |
| Jules Stein Eye Institute/ UCLA | Los Angeles | California | 90095 | — |
| Northern California Retina-Vitreous Associates | Mountain View | California | 94040 | — |
| East Bay Retina Consultants | Oakland | California | 94609 | — |
| Doheny Eye Institute | Pasadena | California | 91105 | — |
| California Eye Specialists Medical Group | Pasadena | California | 91107 | — |
| Retina Consultants Medical Group | Sacramento | California | 95841 | — |
| Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California | 94110 | — |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | — |
| California Retina Consultants;Research Department | Santa Barbara | California | 93103 | — |
| Eye Center of Northern Colorado | Fort Collins | Colorado | 80528 | — |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | — |
| Retina Group of New England | Waterford | Connecticut | 06385 | — |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | — |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | — |
| Retina Specialty Institute | Pensacola | Florida | 32503 | — |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | — |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | — |
| Southern Vitreoretinal Associates;Research | Tallahassee | Florida | 32308 | — |
| Retina Associates of Florida;Retina Associates of Florida | Tampa | Florida | 33609 | — |
| Southeast Retina Center | Augusta | Georgia | 30909 | — |
| Georgia Retina | Marietta | Georgia | 30060 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Illinois Retina Associates | Joliet | Illinois | 60435 | — |
| University Retina | Lemont | Illinois | 60439 | — |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | — |
| Retina Associates | Lenexa | Kansas | 66215 | — |
| Retina & Vitreous Associates of Kentucky | Lexington | Kentucky | 40509 | — |
| Maine Eye Center | Portland | Maine | 04605 | — |
| The Retina Care Center | Baltimore | Maryland | 21209 | — |
| Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst | Baltimore | Maryland | 21287 | — |
| The Retina Group of Washington;Retinal Disease | Chevy Chase | Maryland | 20815 | — |
| Cumberland Valley Retina Consultants;Clinical Research | Hagerstown | Maryland | 21740 | — |
| Retina Specialist | Towson | Maryland | 21204 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| Vitreo Retinal Associates | Worcester | Massachusetts | 01605 | — |
| Retina Specialists Of Michigan | Grand Rapids | Michigan | 49546 | — |
| Associated Retinal Consultants - Royal Oak | Royal Oak | Michigan | 48073 | — |
| VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota | Minneapolis | Minnesota | 55435 | — |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | — |
| Retina Institute | St Louis | Missouri | 63128 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| Envision Ocular, LLC | Bloomfield | New Jersey | 07003 | — |
| Retina Associates of New Jersey | Teaneck | New Jersey | 07666 | — |
| Long Island Vitreoretinal Consultants;Opthalmology | Great Neck | New York | 11021 | — |
| Retina Vitreous Surgeons of Central New York | Liverpool | New York | 13088 | — |
| New York University (NYU) | New York | New York | 10017 | — |
| Ophthalmic Consultants of Long Island | Oceanside | New York | 11572 | — |
| Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research | Asheville | North Carolina | 28803 | — |
| Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina | Charlotte | North Carolina | 28210 | — |
| Duke Eye Center | Durham | North Carolina | 27705 | — |
| Graystone Eye;Clinical Research | Hickory | North Carolina | 28602 | — |
| Cincinnati Eye Institute;Retina | Cincinnati | Ohio | 45242 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State Havener Eye Institute;Ophthalmology Research | Columbus | Ohio | 43212 | — |
| Midwest Retina;Retina/Vitreous | Dublin | Ohio | 43016 | — |
| Retina Vitreous Center - Glen Eagles | Edmond | Oklahoma | 73013 | — |
| Retina Northwest;Research Department | Portland | Oregon | 97221 | — |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | — |
| Charleston Neuroscience | Ladson | South Carolina | 29456 | — |
| Carolina Eyecare Physicians | Mt. Pleasant | South Carolina | 29464 | — |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | — |
| Charles Retina Institution;Retina surgery | Germantown | Tennessee | 38138 | — |
| Tennessee Retina | Nashville | Tennessee | 37203 | — |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | — |
| Texas Retina Associates | Arlington | Texas | 76012 | — |
| Austin Research Center for Retina | Austin | Texas | 78705 | — |
| Austin Retina Associates;Opthalmology | Austin | Texas | 78705 | — |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | — |
| Retina & Vitreous of Texas | Bellaire | Texas | 77401 | — |
| Texas Retina Associates;Research | Dallas | Texas | 75231 | — |
| Texas Retina Associates | Fort Worth | Texas | 76104 | — |
| Retina Consultants of Texas | Houston | Texas | 77401 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Rocky Mountain Retina Consultants | Murray | Utah | 84107 | — |
| Retina Associates of Utah, PLLC;Clinical Research | Salt Lake City | Utah | 84107 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Wagner Kapoor Institute;Opthalmology | Norfolk | Virginia | 23502 | — |
| Retina Institute of Virginia | Richmond | Virginia | 23235 | — |
| Pacific Northwest Retina | Silverdale | Washington | 98383 | — |
| Spokane Eye Clinical Research;Spokane Eye Surgery Center | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04108156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04108156 live on ClinicalTrials.gov.