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

ClinicalTrials.gov ID: NCT04108156

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.

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ClinicalTrials.gov public records Last synced May 4, 2026, 3:22 PM EDT

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)

Study identification

NCT ID: NCT04108156
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 634 participants

Conditions and interventions

Conditions

Diabetic Macular Edema

Interventions

Intravitreal Ranibizumab 0.5 mg Injection Drug
PDS Implant Pre-Filled with 100 mg/mL Ranibizumab 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 29, 2019
Primary completion: Nov 15, 2027
Completion: Nov 15, 2027
Last update posted: Mar 5, 2026

2019 – 2027

United States locations

U.S. sites: 91
U.S. states: 30
U.S. cities: 84

Facility	City	State	ZIP	Site status
Barnet Dulaney Perkins Eye Center	Mesa	Arizona	85206	Completed
Retinal Consultants of Arizona;Opthalmology	Phoenix	Arizona	85014	Completed
Arizona Retina and Vitreous Consultants	Phoenix	Arizona	85016	Completed
Associated Retina Consultants	Phoenix	Arizona	85020	Completed
California Retina Consultants	Bakersfield	California	93309	Recruiting
Retina-Vitreous Associates Medical Group	Beverly Hills	California	90211	Completed
The Retina Partners	Encino	California	91436	Completed
Retina Consultants of Orange County;Clinical Research	Fullerton	California	92835	Recruiting
Jules Stein Eye Institute/ UCLA	Los Angeles	California	90095	Completed
Northern California Retina-Vitreous Associates	Mountain View	California	94040	Completed
East Bay Retina Consultants	Oakland	California	94609	Recruiting
Doheny Eye Institute	Pasadena	California	91105	Completed
California Eye Specialists Medical Group	Pasadena	California	91107	Completed
Retina Consultants Medical Group	Sacramento	California	95841	Recruiting
Zuckerberg San Francisco General Hospital and Trauma Center	San Francisco	California	94110	Completed
Orange County Retina Medical Group	Santa Ana	California	92705	Recruiting
California Retina Consultants;Research Department	Santa Barbara	California	93103	Completed
Eye Center of Northern Colorado	Fort Collins	Colorado	80528	Completed
Colorado Clinical Research	Lakewood	Colorado	80228	Completed
Retina Group of New England	Waterford	Connecticut	06385	Active, not recruiting
Retina Group of Florida	Fort Lauderdale	Florida	33308	Completed
National Ophthalmic Research Institute	Fort Myers	Florida	33912	Completed
Retina Specialty Institute	Pensacola	Florida	32503	Recruiting
Fort Lauderdale Eye Institute	Plantation	Florida	33324	Recruiting
Retina Vitreous Associates of Florida	St. Petersburg	Florida	33711	Recruiting
Southern Vitreoretinal Associates;Research	Tallahassee	Florida	32308	Recruiting
Retina Associates of Florida;Retina Associates of Florida	Tampa	Florida	33609	Completed
Southeast Retina Center	Augusta	Georgia	30909	Recruiting
Georgia Retina	Marietta	Georgia	30060	Completed
Northwestern Memorial Hospital	Chicago	Illinois	60611	Completed
Illinois Retina Associates	Joliet	Illinois	60435	Completed
University Retina	Lemont	Illinois	60439	Completed
Wolfe Eye Clinic	West Des Moines	Iowa	50266	Completed
Retina Associates	Lenexa	Kansas	66215	Completed
Retina & Vitreous Associates of Kentucky	Lexington	Kentucky	40509	Completed
Maine Eye Center	Portland	Maine	04605	Active, not recruiting
The Retina Care Center	Baltimore	Maryland	21209	Withdrawn
Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst	Baltimore	Maryland	21287	Completed
The Retina Group of Washington;Retinal Disease	Chevy Chase	Maryland	20815	Recruiting
Cumberland Valley Retina Consultants;Clinical Research	Hagerstown	Maryland	21740	Recruiting
Retina Specialist	Towson	Maryland	21204	Completed
Tufts Medical Center	Boston	Massachusetts	02111	Active, not recruiting
Ophthalmic Consultants of Boston	Boston	Massachusetts	02114	Completed
Vitreo Retinal Associates	Worcester	Massachusetts	01605	Completed
Retina Specialists Of Michigan	Grand Rapids	Michigan	49546	Completed
Associated Retinal Consultants - Royal Oak	Royal Oak	Michigan	48073	Completed
VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota	Minneapolis	Minnesota	55435	Completed
Pepose Vision Institute	Chesterfield	Missouri	63017	Completed
Retina Institute	St Louis	Missouri	63128	Completed
Sierra Eye Associates	Reno	Nevada	89502	Recruiting
Envision Ocular, LLC	Bloomfield	New Jersey	07003	Completed
Retina Associates of New Jersey	Teaneck	New Jersey	07666	Active, not recruiting
Long Island Vitreoretinal Consultants;Opthalmology	Great Neck	New York	11021	Completed
Retina Vitreous Surgeons of Central New York	Liverpool	New York	13088	Recruiting
New York University (NYU)	New York	New York	10012	Completed
Ophthalmic Consultants of Long Island	Oceanside	New York	11572	Completed
Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research	Asheville	North Carolina	28803	Completed
Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina	Charlotte	North Carolina	28210	Completed
Duke Eye Center	Durham	North Carolina	27705	Completed
Graystone Eye;Clinical Research	Hickory	North Carolina	28602	Completed
Cape Fear Retinal Associates	Wilmington	North Carolina	28401	Withdrawn
Cincinnati Eye Institute;Retina	Cincinnati	Ohio	45242	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Completed
Ohio State Havener Eye Institute;Ophthalmology Research	Columbus	Ohio	43212	Recruiting
Midwest Retina;Retina/Vitreous	Dublin	Ohio	43016	Completed
Retina Vitreous Center - Glen Eagles	Edmond	Oklahoma	73013	Completed
Retina Northwest;Research Department	Portland	Oregon	97221	Completed
Cumberland Valley Retina Consultants	Chambersburg	Pennsylvania	17201	Withdrawn
Mid Atlantic Retina	Philadelphia	Pennsylvania	19107	Completed
Charleston Neuroscience	Ladson	South Carolina	29456	Completed
Carolina Eyecare Physicians	Mt. Pleasant	South Carolina	29464	Completed
Palmetto Retina Center	West Columbia	South Carolina	29169	Withdrawn
Charles Retina Institution;Retina surgery	Germantown	Tennessee	38138	Recruiting
Tennessee Retina	Nashville	Tennessee	37203	Active, not recruiting
Retina Research Institute of Texas	Abilene	Texas	79606	Completed
Texas Retina Associates	Arlington	Texas	76012	Completed
Austin Research Center for Retina	Austin	Texas	78705	Completed
Austin Retina Associates;Opthalmology	Austin	Texas	78705	Completed
Austin Clinical Research, LLC	Austin	Texas	78750	Completed
Retina & Vitreous of Texas	Bellaire	Texas	77401	Recruiting
Texas Retina Associates;Research	Dallas	Texas	75231	Completed
Texas Retina Associates	Fort Worth	Texas	76104	Completed
Retina Consultants of Texas	Houston	Texas	77401	Recruiting
Medical Center Ophthalmology Associates	San Antonio	Texas	78240	Recruiting
Rocky Mountain Retina Consultants	Murray	Utah	84107	Completed
Retina Associates of Utah, PLLC;Clinical Research	Salt Lake City	Utah	84107	Completed
Piedmont Eye Center	Lynchburg	Virginia	24502	Completed
Wagner Kapoor Institute;Opthalmology	Norfolk	Virginia	23502	Completed
Retina Institute of Virginia	Richmond	Virginia	23235	Completed
Pacific Northwest Retina	Silverdale	Washington	98383	Completed
Spokane Eye Clinical Research;Spokane Eye Surgery Center	Spokane	Washington	99204	Recruiting

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 Mar 5, 2026 · Synced May 4, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04108156 live on ClinicalTrials.gov.

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