Phase
Condition
Diabetic Retinopathy
Retina
Treatment
PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Intravitreal Ranibizumab 0.5 mg Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Emanuelli Research & Development Center
Arecibo, 612
Puerto RicoSite Not Available
Emanuelli Research and Development Center LLC
Arecibo, 00612
Puerto RicoSite Not Available
Berrocal and Associates
San Juan, 00907
Puerto RicoSite Not Available
Trinity Research Group
Dothan, Alabama 36301
United StatesSite Not Available
Barnet Dulaney Perkins Eye Center
Mesa, Arizona 85206
United StatesSite Not Available
Associated Retina Consultants
Phoenix, Arizona 85020
United StatesSite Not Available
Retinal Consultants of Arizona;Opthalmology
Phoenix, Arizona 85014
United StatesSite Not Available
California Retina Consultants
Bakersfield, California 93309
United StatesSite Not Available
The Retina Partners
Encino, California 91436
United StatesSite Not Available
Retina Consultants of Orange County
Fullerton, California 92835-3424
United StatesSite Not Available
Retina Consultants of Orange County;Clinical Research
Fullerton, California 92835
United StatesSite Not Available
Jules Stein Eye Institute/ UCLA
Los Angeles, California 90095
United StatesSite Not Available
N CA Retina Vitreous Assoc
Mountain View, California 94040
United StatesSite Not Available
California Eye Specialists Medical Group
Pasadena, California 91107
United StatesSite Not Available
California Eye Specialists Medical group Inc.
Pasadena, California 91107
United StatesSite Not Available
Kaiser Permanente Riverside Medical Center
Riverside, California 92505
United StatesSite Not Available
Kaiser Permanente;RESEARCH AND EVALUATION
Riverside, California 92505
United StatesSite Not Available
Retina Consultants Medical Group
Sacramento, California 95841
United StatesSite Not Available
Retinal Consultants Med Group
Sacramento, California 95825
United StatesSite Not Available
Zuckerberg San Francisco General Hospital
San Francisco, California 94110
United StatesSite Not Available
Orange County Retina Med Group
Santa Ana, California 92705
United StatesSite Not Available
Orange County Retina Medical Group
Santa Ana, California 92705
United StatesSite Not Available
California Retina Consultants
Santa Barbara, California 93103
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Southwest Retina Consultants
Durango, Colorado 81303
United StatesSite Not Available
Southwest Retina Research Center
Durango, Colorado 81303
United StatesSite Not Available
Eye Center of Northern CO
Fort Collins, Colorado 80528
United StatesSite Not Available
Colorado Retina Associates, PC
Golden, Colorado 80401
United StatesSite Not Available
Colorado Clinical Research
Lakewood, Colorado 80228
United StatesSite Not Available
Colorado Retina Associates, PC
Lakewood, Colorado 80228
United StatesSite Not Available
Retina Group of New England
Waterford, Connecticut 06385
United StatesSite Not Available
Retina Specialty Institute
Pensacola, Florida 32503
United StatesSite Not Available
Fort Lauderdale Eye Institute
Plantation, Florida 33324
United StatesSite Not Available
Southern Vitreoretinal Assoc
Tallahassee, Florida 32308
United StatesSite Not Available
Retina Associates of Florida, LLC
Tampa, Florida 33609
United StatesSite Not Available
Retina Associates of Florida;Retina Associates of Florida
Tampa, Florida 33609
United StatesSite Not Available
Southeast Retina Center
Augusta, Georgia 30909
United StatesSite Not Available
Georgia Retina
Marietta, Georgia 30060
United StatesSite Not Available
Georgia Retina PC
Marietta, Georgia 30060-1137
United StatesSite Not Available
Retina Consultants of Hawaii
'Aiea, Hawaii 96701
United StatesSite Not Available
Retina Consultants of Hawaii at Pali Momi Medical Center
'Aiea, Hawaii 96701
United StatesSite Not Available
Northwestern Medical Group/Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Illinois Retina Associates
Joliet, Illinois 60435
United StatesSite Not Available
University Retina
Lemont, Illinois 60439
United StatesSite Not Available
University Retina and Macula Associates, PC
Oak Forest, Illinois 60452
United StatesSite Not Available
Wolfe Eye Clinic
West Des Moines, Iowa 50266
United StatesSite Not Available
Retina Associates
Lenexa, Kansas 66215
United StatesSite Not Available
Retina Associates
Shawnee Mission, Kansas 66204
United StatesSite Not Available
Maine Eye Center
Portland, Maine 04605
United StatesSite Not Available
Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst
Baltimore, Maryland 21287
United StatesSite Not Available
The Retina Care Center
Baltimore, Maryland 21209
United StatesSite Not Available
Retina Group of Washington
Chevy Chase, Maryland 20815
United StatesSite Not Available
Cumberland Valley Retina Associates
Hagerstown, Maryland 21740
United StatesSite Not Available
Cumberland Valley Retina Consultants;Clinical Research
Hagerstown, Maryland 21740
United StatesSite Not Available
Retina Specialists
Towson, Maryland 21204
United StatesSite Not Available
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Foundation for Vision Research
Grand Rapids, Michigan 49546
United StatesSite Not Available
Associated Retinal Consultants - Royal Oak
Royal Oak, Michigan 48073
United StatesSite Not Available
Associated Retinal Consultants PC
Royal Oak, Michigan 48073
United StatesSite Not Available
Vitreo Retinal Surgery
Minneapolis, Minnesota 55435
United StatesSite Not Available
VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota
Minneapolis, Minnesota 55435
United StatesSite Not Available
Midwest Vision Research Foundation
Chesterfield, Missouri 63017
United StatesSite Not Available
Pepose Vision Institute
Chesterfield, Missouri 63017
United StatesSite Not Available
Sierra Eye Associates
Reno, Nevada 89502
United StatesSite Not Available
Envision Ocular, LLC
Bloomfield, New Jersey 07003
United StatesSite Not Available
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey 08034
United StatesSite Not Available
Retina Associates of NJ
Teaneck, New Jersey 07666
United StatesSite Not Available
Retina Associates of New Jersey
Teaneck, New Jersey 07666
United StatesSite Not Available
Retina Associates of NJ
Toms River, New Jersey 08755
United StatesSite Not Available
Long Is. Vitreoretinal Consult
Great Neck, New York 11021
United StatesSite Not Available
Retina Vit Surgeons/Central NY
Liverpool, New York 13088
United StatesSite Not Available
Retina Vitreous Surgeons of Central New York
Liverpool, New York 13088
United StatesSite Not Available
New York University
New York, New York 10017
United StatesSite Not Available
New York University (NYU)
New York, New York 10012
United StatesSite Not Available
University of Rochester Flaum Eye Institute
Rochester, New York 14642
United StatesSite Not Available
Retina Vit Surgeons/Central NY
Syracuse, New York 13224
United StatesSite Not Available
Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research
Asheville, North Carolina 28803
United StatesSite Not Available
Western Carolina Retinal Associate PA
Asheville, North Carolina 28803
United StatesSite Not Available
Char Eye Ear &Throat Assoc
Charlotte, North Carolina 28210
United StatesSite Not Available
Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina
Charlotte, North Carolina 28210
United StatesSite Not Available
Duke Eye Center
Durham, North Carolina 27705
United StatesSite Not Available
Cape Fear Retinal Associates
Wilmington, North Carolina 28401
United StatesSite Not Available
Cincinnati Eye Institute
Cincinnati, Ohio 45242
United StatesSite Not Available
Ohio State Havener Eye Institute;Ophthalmology Research
Columbus, Ohio 43212
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Retina Vitreous Center
Edmond, Oklahoma 73013
United StatesSite Not Available
Retina Vitreous Center - Glen Eagles
Edmond, Oklahoma 73013
United StatesSite Not Available
Retina Northwest;Research Department
Portland, Oregon 97221
United StatesSite Not Available
Cumberland Valley Retina Consultants; Chambersburg
Chambersburg, Pennsylvania 17201
United StatesSite Not Available
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Mid Atlantic Retina;Retina Research
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Palmetto Retina Center
Florence, South Carolina 29501
United StatesSite Not Available
Charleston Neuroscience
Ladson, South Carolina 29456
United StatesSite Not Available
Charleston Neuroscience Inst
Ladson, South Carolina 29456
United StatesSite Not Available
Carolina Eyecare Physicians
Mount Pleasant, South Carolina 29464
United StatesSite Not Available
Palmetto Retina Center
West Columbia, South Carolina 29169
United StatesSite Not Available
Charles Retina Institute
Germantown, Tennessee 38138
United StatesSite Not Available
Charles Retina Institution;Retina surgery
Germantown, Tennessee 38138
United StatesSite Not Available
Southeastern Retina Associates
Knoxville, Tennessee 37922
United StatesSite Not Available
Charles Retina Institute
Memphis, Tennessee 38119
United StatesSite Not Available
Tennessee Retina
Nashville, Tennessee 37203
United StatesSite Not Available
Tennessee Retina PC
Nashville, Tennessee 37203
United StatesSite Not Available
Retina Res Institute of Texas
Abilene, Texas 79606
United StatesSite Not Available
Retina Research Institute of Texas
Abilene, Texas 79606
United StatesSite Not Available
Texas Retina Associates
Arlington, Texas 76012
United StatesSite Not Available
Austin Retina Associates
Austin, Texas 78705-1169
United StatesSite Not Available
Austin Retina Associates;Opthalmology
Austin, Texas 78705
United StatesSite Not Available
Retina & Vitreous of Texas
Bellaire, Texas 77401
United StatesSite Not Available
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesSite Not Available
Texas Retina Associates
Dallas, Texas 75231
United StatesSite Not Available
Texas Retina Associates;Research
Dallas, Texas 75231
United StatesSite Not Available
Texas Retina Associates
Fort Worth, Texas 76104
United StatesSite Not Available
Retina Center of Texas
Grapevine, Texas 76051
United StatesSite Not Available
Retina & Vitreous of Texas
Houston, Texas 77025
United StatesSite Not Available
Retina Consultants of Texas
Houston, Texas 77401
United StatesSite Not Available
Med Center Ophthalmology Assoc
San Antonio, Texas 78240
United StatesSite Not Available
Medical Center Ophthalmology Associates
San Antonio, Texas 78240
United StatesSite Not Available
Retina Center of Texas
Southlake, Texas 76092
United StatesSite Not Available
Retina Consultants of Texas
The Woodlands, Texas 77384-4167
United StatesSite Not Available
Rocky Mountain Retina Consultants
Murray, Utah 84107
United StatesSite Not Available
Retina Associates of Utah
Salt Lake City, Utah 84107
United StatesSite Not Available
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
Rocky Mountain Retina
Salt Lake City, Utah 84107
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesSite Not Available
Wagner Kapoor Institute;Opthalmology
Norfolk, Virginia 23502
United StatesSite Not Available
Wagner Macula & Retina Center
Norfolk, Virginia 23451
United StatesSite Not Available
Retina Institute of Virginia
Richmond, Virginia 23235
United StatesSite Not Available
Pacific Northwest Retina
Silverdale, Washington 98383
United StatesSite Not Available
Retina Center Northwest
Silverdale, Washington 98383
United StatesSite Not Available
Spokane Eye Clinical Research
Spokane, Washington 99204
United StatesSite Not Available
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington 99204
United StatesSite Not Available
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