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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

August 10, 2020

Primary Completion Date

October 3, 2022

Study Completion Date

June 13, 2025

Conditions
Diabetic Retinopathy
Interventions
DRUG

PDS Implant Pre-Filled with 100 mg/mL Ranibizumab

Will be administered as per the schedule described in individual arm.

DRUG

Intravitreal Ranibizumab 0.5 mg Injection

Will be administered as per the schedule described in individual arm.

Trial Locations (64)

612

Emanuelli Research & Development Center, Arecibo

10012

New York University (NYU), New York

13088

Retina Vitreous Surgeons of Central New York, Liverpool

19107

Mid Atlantic Retina;Retina Research, Philadelphia

21209

The Retina Care Center, Baltimore

21287

Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst, Baltimore

21740

Cumberland Valley Retina Consultants;Clinical Research, Hagerstown

23235

Retina Institute of Virginia, Richmond

23502

Wagner Kapoor Institute;Opthalmology, Norfolk

24502

Piedmont Eye Center, Lynchburg

27705

Duke Eye Center, Durham

28210

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

28401

Cape Fear Retinal Associates, Wilmington

28803

Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research, Asheville

29169

Palmetto Retina Center, West Columbia

29456

Charleston Neuroscience, Ladson

30060

Georgia Retina, Marietta

30909

Southeast Retina Center, Augusta

32503

Retina Specialty Institute, Pensacola

33324

Fort Lauderdale Eye Institute, Plantation

33609

Retina Associates of Florida;Retina Associates of Florida, Tampa

37203

Tennessee Retina, Nashville

37922

Southeastern Retina Associates, Knoxville

38138

Charles Retina Institution;Retina surgery, Germantown

43212

Ohio State Havener Eye Institute;Ophthalmology Research, Columbus

48073

Associated Retinal Consultants - Royal Oak, Royal Oak

55435

VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota, Minneapolis

60435

Illinois Retina Associates, Joliet

60439

University Retina, Lemont

60611

Northwestern Memorial Hospital, Chicago

63017

Pepose Vision Institute, Chesterfield

66215

Retina Associates, Lenexa

73013

Retina Vitreous Center - Glen Eagles, Edmond

75231

Texas Retina Associates;Research, Dallas

76051

Retina Center of Texas, Grapevine

77401

Retina & Vitreous of Texas, Bellaire

Retina Consultants of Texas, Houston

78240

Medical Center Ophthalmology Associates, San Antonio

78705

Austin Retina Associates;Opthalmology, Austin

79606

Retina Research Institute of Texas, Abilene

80228

Colorado Clinical Research, Lakewood

81303

Southwest Retina Research Center, Durango

84107

Rocky Mountain Retina Consultants, Murray

Retina Associates of Utah, PLLC;Clinical Research, Salt Lake City

85014

Retinal Consultants of Arizona;Opthalmology, Phoenix

85020

Associated Retina Consultants, Phoenix

85206

Barnet Dulaney Perkins Eye Center, Mesa

89502

Sierra Eye Associates, Reno

90095

Jules Stein Eye Institute/ UCLA, Los Angeles

91107

California Eye Specialists Medical Group, Pasadena

91436

The Retina Partners, Encino

92505

Kaiser Permanente;RESEARCH AND EVALUATION, Riverside

92705

Orange County Retina Medical Group, Santa Ana

92835

Retina Consultants of Orange County;Clinical Research, Fullerton

93309

California Retina Consultants, Bakersfield

95841

Retina Consultants Medical Group, Sacramento

96701

Retina Consultants of Hawaii at Pali Momi Medical Center, ‘Aiea

97221

Retina Northwest;Research Department, Portland

98383

Pacific Northwest Retina, Silverdale

99204

Spokane Eye Clinical Research;Spokane Eye Surgery Center, Spokane

06385

Retina Group of New England, Waterford

04605

Maine Eye Center, Portland

07003

Envision Ocular, LLC, Bloomfield

07666

Retina Associates of New Jersey, Teaneck

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04503551 - 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 | Biotech Hunter | Biotech Hunter