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

Last updated: January 15, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetic Retinopathy

Retina

Treatment

PDS Implant Pre-Filled with 100 mg/mL Ranibizumab

Intravitreal Ranibizumab 0.5 mg Injection

Clinical Study ID

NCT04503551
GR41675
  • Ages > 18
  • All Genders

Study Summary

Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm

Eligibility Criteria

Inclusion

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 ≤12% within 2 months prior to screening or at screening

Inclusion Criteria for Study Eye

  • Moderately severe or severe NPDR (ETDRS-DRSS level 47 or 53)

  • BCVA score of ≥ 69 letters (20/40 approximate Snellen equivalent or better)

Exclusion

Exclusion Criteria:

  • Uncontrolled blood pressure

  • Cerebrovascular accident or myocardial infarction within 6 months prior torandomization

  • 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, oranticipated to require hemodialysis or peritoneal dialysis at any time during thestudy

  • History of other disease, other non-diabetic metabolic dysfunction, physicalexamination finding, or clinical laboratory finding giving reasonable suspicion of acondition that contraindicates the use of ranibizumab or surgical placement of thePDS implant; that might affect interpretation of the results of the study; or thatrenders the patient at high risk for treatment complications in the opinion of theinvestigator or Sponsor

Ocular Exclusion Criteria for Study Eye:

  • 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® implantsat 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 torandomization

  • Any PRP at any time prior to randomization

  • Any macular laser photocoagulation (such as micropulse and focal or grid laser) atany time prior to randomization

  • Active intraocular inflammation (grade trace or above)

  • Clinically significant abnormalities of the vitreous-retinal interface involving themacular area or disrupting the macular architecture, such as vitreous-retinaltraction or epiretinal membrane (assessed by the investigator and confirmed by thecentral reading center)

  • Uncontrolled ocular hypertension or glaucoma and any such condition the investigatordetermines may require a glaucoma-filtering surgery during a participant'sparticipation in the study

  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucomasurgery

  • Any concurrent ocular condition (e.g., cataract, epiretinal membrane) that wouldrequire surgical intervention during the study to prevent or treat visual loss thatmight result from that condition

  • Any concurrent ocular condition (e.g., amblyopia, strabismus) that may affectinterpretation of study results

  • History of other ocular diseases that gives reasonable suspicion of a disease orcondition that contraindicates the use of ranibizumab, that might affectinterpretation of study results, or that renders the participant at high risk fortreatment complications

Ocular Exclusion Criteria for Either Eye

  • Suspected or active ocular or periocular infection of either eye

  • Any history uveitis including idiopathic, drug-associated or autoimmune-associateduveitis

Study Design

Total Participants: 174
Treatment Group(s): 2
Primary Treatment: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Phase: 3
Study Start date:
August 10, 2020
Estimated Completion Date:
June 13, 2025

Connect with a study center

  • Emanuelli Research & Development Center

    Arecibo, 612
    Puerto Rico

    Site Not Available

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Berrocal and Associates

    San Juan, 00907
    Puerto Rico

    Site Not Available

  • Trinity Research Group

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Retinal Consultants of Arizona;Opthalmology

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Site Not Available

  • The Retina Partners

    Encino, California 91436
    United States

    Site Not Available

  • Retina Consultants of Orange County

    Fullerton, California 92835-3424
    United States

    Site Not Available

  • Retina Consultants of Orange County;Clinical Research

    Fullerton, California 92835
    United States

    Site Not Available

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • N CA Retina Vitreous Assoc

    Mountain View, California 94040
    United States

    Site Not Available

  • California Eye Specialists Medical Group

    Pasadena, California 91107
    United States

    Site Not Available

  • California Eye Specialists Medical group Inc.

    Pasadena, California 91107
    United States

    Site Not Available

  • Kaiser Permanente Riverside Medical Center

    Riverside, California 92505
    United States

    Site Not Available

  • Kaiser Permanente;RESEARCH AND EVALUATION

    Riverside, California 92505
    United States

    Site Not Available

  • Retina Consultants Medical Group

    Sacramento, California 95841
    United States

    Site Not Available

  • Retinal Consultants Med Group

    Sacramento, California 95825
    United States

    Site Not Available

  • Zuckerberg San Francisco General Hospital

    San Francisco, California 94110
    United States

    Site Not Available

  • Orange County Retina Med Group

    Santa Ana, California 92705
    United States

    Site Not Available

  • Orange County Retina Medical Group

    Santa Ana, California 92705
    United States

    Site Not Available

  • California Retina Consultants

    Santa Barbara, California 93103
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Southwest Retina Consultants

    Durango, Colorado 81303
    United States

    Site Not Available

  • Southwest Retina Research Center

    Durango, Colorado 81303
    United States

    Site Not Available

  • Eye Center of Northern CO

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Colorado Retina Associates, PC

    Golden, Colorado 80401
    United States

    Site Not Available

  • Colorado Clinical Research

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Colorado Retina Associates, PC

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Retina Group of New England

    Waterford, Connecticut 06385
    United States

    Site Not Available

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Fort Lauderdale Eye Institute

    Plantation, Florida 33324
    United States

    Site Not Available

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Retina Associates of Florida, LLC

    Tampa, Florida 33609
    United States

    Site Not Available

  • Retina Associates of Florida;Retina Associates of Florida

    Tampa, Florida 33609
    United States

    Site Not Available

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Georgia Retina

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Georgia Retina PC

    Marietta, Georgia 30060-1137
    United States

    Site Not Available

  • Retina Consultants of Hawaii

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Retina Consultants of Hawaii at Pali Momi Medical Center

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Northwestern Medical Group/Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Illinois Retina Associates

    Joliet, Illinois 60435
    United States

    Site Not Available

  • University Retina

    Lemont, Illinois 60439
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Wolfe Eye Clinic

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Retina Associates

    Lenexa, Kansas 66215
    United States

    Site Not Available

  • Retina Associates

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • Maine Eye Center

    Portland, Maine 04605
    United States

    Site Not Available

  • Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • The Retina Care Center

    Baltimore, Maryland 21209
    United States

    Site Not Available

  • Retina Group of Washington

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Cumberland Valley Retina Associates

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants;Clinical Research

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Retina Specialists

    Towson, Maryland 21204
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Foundation for Vision Research

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Associated Retinal Consultants - Royal Oak

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Associated Retinal Consultants PC

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Vitreo Retinal Surgery

    Minneapolis, Minnesota 55435
    United States

    Site Not Available

  • VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota

    Minneapolis, Minnesota 55435
    United States

    Site Not Available

  • Midwest Vision Research Foundation

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Pepose Vision Institute

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Site Not Available

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Mid Atlantic Retina - Wills Eye Hospital

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Retina Associates of NJ

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Retina Associates of New Jersey

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Retina Associates of NJ

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Long Is. Vitreoretinal Consult

    Great Neck, New York 11021
    United States

    Site Not Available

  • Retina Vit Surgeons/Central NY

    Liverpool, New York 13088
    United States

    Site Not Available

  • Retina Vitreous Surgeons of Central New York

    Liverpool, New York 13088
    United States

    Site Not Available

  • New York University

    New York, New York 10017
    United States

    Site Not Available

  • New York University (NYU)

    New York, New York 10012
    United States

    Site Not Available

  • University of Rochester Flaum Eye Institute

    Rochester, New York 14642
    United States

    Site Not Available

  • Retina Vit Surgeons/Central NY

    Syracuse, New York 13224
    United States

    Site Not Available

  • Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Duke Eye Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cape Fear Retinal Associates

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Ohio State Havener Eye Institute;Ophthalmology Research

    Columbus, Ohio 43212
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Retina Vitreous Center

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Retina Vitreous Center - Glen Eagles

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Retina Northwest;Research Department

    Portland, Oregon 97221
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants; Chambersburg

    Chambersburg, Pennsylvania 17201
    United States

    Site Not Available

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Mid Atlantic Retina;Retina Research

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Palmetto Retina Center

    Florence, South Carolina 29501
    United States

    Site Not Available

  • Charleston Neuroscience

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Charleston Neuroscience Inst

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Carolina Eyecare Physicians

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Charles Retina Institution;Retina surgery

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Southeastern Retina Associates

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Charles Retina Institute

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Tennessee Retina

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Retina PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Retina Res Institute of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705-1169
    United States

    Site Not Available

  • Austin Retina Associates;Opthalmology

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina & Vitreous of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Retina Associates;Research

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Retina Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Retina Center of Texas

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Retina & Vitreous of Texas

    Houston, Texas 77025
    United States

    Site Not Available

  • Retina Consultants of Texas

    Houston, Texas 77401
    United States

    Site Not Available

  • Med Center Ophthalmology Assoc

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Center of Texas

    Southlake, Texas 76092
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 77384-4167
    United States

    Site Not Available

  • Rocky Mountain Retina Consultants

    Murray, Utah 84107
    United States

    Site Not Available

  • Retina Associates of Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Retina Associates of Utah, PLLC;Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Rocky Mountain Retina

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Wagner Kapoor Institute;Opthalmology

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Wagner Macula & Retina Center

    Norfolk, Virginia 23451
    United States

    Site Not Available

  • Retina Institute of Virginia

    Richmond, Virginia 23235
    United States

    Site Not Available

  • Pacific Northwest Retina

    Silverdale, Washington 98383
    United States

    Site Not Available

  • Retina Center Northwest

    Silverdale, Washington 98383
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

  • Spokane Eye Clinical Research;Spokane Eye Surgery Center

    Spokane, Washington 99204
    United States

    Site Not Available

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