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This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab (Pagoda)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04108156
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab Drug: Intravitreal Ranibizumab 0.5 mg Injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: PDS Arm
Participants randomized to the PDS arm will receive intravitreal ranibizumab injection every 4 weeks (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 every 24-weeks (Q24W) thereafter
Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.

Active Comparator: Intravitreal Arm
Participants randomized to the intravitreal arm will receive intravitreal ranibizumab injection every 4 weeks until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.
Drug: Intravitreal Ranibizumab 0.5 mg Injection
Will be administered as per the schedule described in individual arm.




Primary Outcome Measures :
  1. Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured using the ETDRS chart [ Time Frame: Baseline to Week 64 ]

    BCVA = Best-Corrected Visual Acuity

    ETDRS = Early Treatment Diabetic Retinopathy Study

    A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.



Secondary Outcome Measures :
  1. Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 [ Time Frame: Baseline to Week 64 ]
    ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale

  2. Change from baseline in BCVA as measured on the ETDRS chart over time [ Time Frame: Baseline up to Week 120 ]
  3. Percentage of participants who lose <10, and <5 letters in BCVA from baseline over time [ Time Frame: Baseline up to Week 120 ]
  4. Percentage of participants who gain ≥15, ≥10, ≥5, ≥0 letters in BCVA from baseline over time [ Time Frame: Baseline up to Week 120 ]
  5. Percentage of participants with a BCVA Snellen equivalent of 20/40 or better over time [ Time Frame: Baseline up to Week 120 ]
  6. Percentage of participants with a BCVA Snellen equivalent of 20/200 or worse over time [ Time Frame: Baseline up to Week 120 ]
  7. Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS at Week 64 [ Time Frame: Baseline to Week 64 ]
  8. Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS over time [ Time Frame: Baseline up to Week 120 ]
  9. Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS over time [ Time Frame: Baseline up to Week 120 ]
  10. Percentage of participants with a ≥2-step worsening from baseline on the ETDRS-DRSS over time [ Time Frame: Baseline up to Week 120 ]
  11. Percentage of participants with a ≥3-step worsening from baseline on the ETDRS-DRSS over time [ Time Frame: Baseline up to Week 120 ]
  12. Change from baseline in ETDRS-DRSS score over time [ Time Frame: Baseline up to Week 120 ]
  13. Change from baseline in CST as measured on SD-OCT at Week 64 [ Time Frame: Baseline to Week 64 ]

    CST = central subfield thickness

    SD-OCT = spectral domain optical coherence tomography


  14. Change from baseline in CST as measured on SD-OCT over time [ Time Frame: Baseline up to Week 120 ]
  15. Change from baseline in total macular volume as measured on SD-OCT over time [ Time Frame: Baseline up to Week 120 ]
  16. Percentage of participants with DME (defined as CST ≥325 μm on SD-OCT) over time [ Time Frame: Baseline up to Week 120 ]
    DME = diabetic macular edema

  17. Percentage of participants with PDR (defined as a score ≥60 on the ETDRS-DRSS) over time [ Time Frame: Baseline up to Week 120 ]
    PDR = proliferative diabetic retinopathy

  18. Incidence and severity of ocular adverse events [ Time Frame: Baseline to Week 120 ]
  19. Incidence and severity of non-ocular adverse events [ Time Frame: Baseline up to Week 120 ]
  20. Incidence, severity, and duration of adverse events of special interest [ Time Frame: Baseline up to Week 120 ]
  21. Incidence, severity, and duration of PDS-associated adverse events of special interest during the postoperative period (up to 37 days after initial implantation) and follow-up period (>37 days after implantation surgery) [ Time Frame: Baseline up to Week 120 ]
  22. Serum concentration of ranibizumab observed over time [ Time Frame: Baseline up to Week 120 ]
  23. PK parameter value area under the concentration- time curve over 24 weeks (AUC24W) [ Time Frame: Baseline to Week 24 ]
  24. Pharmacokinetic (PK) parameter maximum serum concentration (Cmax) [ Time Frame: Baseline up to Week 120 ]
  25. PK Parameter minimum serum concentration (Cmin) [ Time Frame: Baseline up to Week 120 ]
  26. PK parameter half-life (t1/2) after PDS implant insertion [ Time Frame: Baseline up to Week 120 ]
  27. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study [ Time Frame: Baseline up to Week 120 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years at time of signing Informed Consent Form
  • Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
  • 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 um on SD-OCT at screening
  • BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)

Exclusion Criteria:

  • High-risk proliferative diabetic retinopathy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108156


Contacts
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Contact: Reference Study ID Number: GR40550 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, Arizona
Barnet Dulaney Perkins Eye Center Recruiting
Mesa, Arizona, United States, 85206
Associated Retina Consultants Recruiting
Phoenix, Arizona, United States, 85020
Arizona Retina and Vitreous Consultants Recruiting
Phoenix, Arizona, United States, 85021
Retinal Consultants of Arizona Recruiting
Phoenix, Arizona, United States, 85053
United States, California
California Retina Consultants Recruiting
Bakersfield, California, United States, 93309
Retina-Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
The Retina Partners Recruiting
Encino, California, United States, 91436
Retina Consultants of Orange County Recruiting
Fullerton, California, United States, 92835
Jules Stein Eye Institute/ UCLA Recruiting
Los Angeles, California, United States, 90095-7000
N CA Retina Vitreous Assoc Not yet recruiting
Mountain View, California, United States, 94040
East Bay Retina Consultants Recruiting
Oakland, California, United States, 94609
Doheny Eye Institute Not yet recruiting
Pasadena, California, United States, 91105
California Eye Specialists Recruiting
Pasadena, California, United States, 91107
Retinal Consultants Med Group Recruiting
Sacramento, California, United States, 95825
Zuckerberg San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Orange County Retina Med Group Recruiting
Santa Ana, California, United States, 92705
California Retina Consultants Active, not recruiting
Santa Barbara, California, United States, 93103
United States, Colorado
Southwest Retina Consultants Withdrawn
Durango, Colorado, United States, 81301
Eye Center of Northern CO Recruiting
Fort Collins, Colorado, United States, 80528
Colorado Retina Associates, PC Recruiting
Golden, Colorado, United States, 80401
United States, Connecticut
Retina Group of New England Recruiting
Waterford, Connecticut, United States, 06385
United States, Florida
Retina Group of Florida Recruiting
Fort Lauderdale, Florida, United States, 33308
National Ophthalmic Research Institute Recruiting
Fort Myers, Florida, United States, 33912
Retina Specialty Institute Recruiting
Pensacola, Florida, United States, 32503
Fort Lauderdale Eye Institute Recruiting
Plantation, Florida, United States, 33324
Retina Vitreous Assoc of FL Recruiting
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Assoc Recruiting
Tallahassee, Florida, United States, 32308
Retina Associates of Florida, LLC Active, not recruiting
Tampa, Florida, United States, 33609
United States, Georgia
Southeast Retina Center Recruiting
Augusta, Georgia, United States, 30909
Georgia Retina PC Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern Medical Group/Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Illinois Retina Associates Recruiting
Joliet, Illinois, United States, 60435
University Retina and Macula Associates, PC Recruiting
Oak Forest, Illinois, United States, 60452
United States, Iowa
Wolfe Eye Clinic Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Retina Associates Recruiting
Shawnee Mission, Kansas, United States, 66204
Vitreo-Retinal Consultants Withdrawn
Wichita, Kansas, United States, 67214
United States, Kentucky
Retina Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
United States, Maine
Maine Eye Center Recruiting
Portland, Maine, United States, 04101
United States, Maryland
The Retina Care Center Recruiting
Baltimore, Maryland, United States, 21209
Johns Hopkins Med; Wilmer Eye Inst Recruiting
Baltimore, Maryland, United States, 21287
Retina Group of Washington Recruiting
Chevy Chase, Maryland, United States, 20815
Cumberland Valley Retina Associates Recruiting
Hagerstown, Maryland, United States, 21740
Retina Specialists Recruiting
Towson, Maryland, United States, 21204
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Vitreo-Retinal Associates, PC Recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Associated Retinal Consultants Active, not recruiting
Grand Rapids, Michigan, United States, 49546
Foundation for Vision Research Active, not recruiting
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Vitreo Retinal Surgery Recruiting
Minneapolis, Minnesota, United States, 55435
United States, Missouri
Midwest Vision Research Foundation Recruiting
Chesterfield, Missouri, United States, 63017
The Retina Institute - Chesterfield Recruiting
Chesterfield, Missouri, United States, 63017
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
Retina Center of New Jersey Recruiting
Bloomfield, New Jersey, United States, 07003
Mid Atlantic Retina - Wills Eye Hospital Recruiting
Cherry Hill, New Jersey, United States, 08034
Retina Associates of NJ Not yet recruiting
Toms River, New Jersey, United States, 08755
United States, New Mexico
University of New Mexico; School of Med Withdrawn
Albuquerque, New Mexico, United States, 87131
United States, New York
Long Is. Vitreoretinal Consult Recruiting
Great Neck, New York, United States, 11021
New York University Not yet recruiting
New York, New York, United States, 10017
New York Weil Cornell Med Ctr Not yet recruiting
New York, New York, United States, 10021
Ophthalmic Cons of Long Island Recruiting
Oceanside, New York, United States, 11572
University of Rochester Flaum Eye Institute Not yet recruiting
Rochester, New York, United States, 14642
Retina Vit Surgeons/Central NY Recruiting
Syracuse, New York, United States, 13224
United States, North Carolina
Western Carolina Retinal Associate PA Recruiting
Asheville, North Carolina, United States, 28803
Char Eye Ear &Throat Assoc Recruiting
Charlotte, North Carolina, United States, 28210
Duke Eye Center Not yet recruiting
Durham, North Carolina, United States, 27705
Cape Fear Retinal Associates Not yet recruiting
Wilmington, North Carolina, United States, 28401
Graystone Eye Recruiting
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Foundation; Cole Eye Institute Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Midwest Retina Recruiting
Dublin, Ohio, United States, 43016
United States, Oklahoma
Retina Vitreous Center Recruiting
Edmond, Oklahoma, United States, 73013
United States, Oregon
Retina Northwest Recruiting
Portland, Oregon, United States, 97221
United States, South Carolina
Palmetto Retina Center Recruiting
Florence, South Carolina, United States, 29501
Charleston Neuroscience Inst Recruiting
Ladson, South Carolina, United States, 29456
Carolina Eyecare Physicians Not yet recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Charles Retina Institute Recruiting
Germantown, Tennessee, United States, 38138
Tennessee Retina PC Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Retina Res Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Texas Retina Associates Recruiting
Arlington, Texas, United States, 76012
Austin Research Center for Retina Not yet recruiting
Austin, Texas, United States, 78705
Austin Retina Associates Recruiting
Austin, Texas, United States, 78705
Retina Research Center Recruiting
Austin, Texas, United States, 78705
Texas Retina Associates Recruiting
Dallas, Texas, United States, 75231
Texas Retina Associates Recruiting
Fort Worth, Texas, United States, 76104
Retina & Vitreous of Texas Recruiting
Houston, Texas, United States, 77025
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Med Center Ophthalmology Assoc Recruiting
San Antonio, Texas, United States, 78240
Retina Consultants of Houston Recruiting
The Woodlands, Texas, United States, 77384
United States, Utah
Retina Associates of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Rocky Mountain Retina Recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
Piedmont Eye Center Recruiting
Lynchburg, Virginia, United States, 24502
Wagner Macula & Retina Center Active, not recruiting
Norfolk, Virginia, United States, 23451
Retina Institute of Virginia Recruiting
Richmond, Virginia, United States, 23235
United States, Washington
Retina Center Northwest Recruiting
Silverdale, Washington, United States, 98383
Spokane Eye Clinical Research Recruiting
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04108156    
Other Study ID Numbers: GR40550
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
Port Delivery System
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents