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

PHASE3RecruitingINTERVENTIONAL
Enrollment

634

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

November 16, 2027

Study Completion Date

November 16, 2027

Conditions
Diabetic Macular Edema
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.

DRUG

Ranibizumab refill exchange

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

Trial Locations (92)

10012

COMPLETED

New York University (NYU), New York

11021

COMPLETED

Long Island Vitreoretinal Consultants;Opthalmology, Great Neck

11572

COMPLETED

Ophthalmic Consultants of Long Island, Oceanside

13088

WITHDRAWN

Retina Vitreous Surgeons of Central New York, Liverpool

17201

WITHDRAWN

Cumberland Valley Retina Consultants, Chambersburg

19107

COMPLETED

Mid Atlantic Retina, Philadelphia

20815

RECRUITING

The Retina Group of Washington;Retinal Disease, Chevy Chase

21204

COMPLETED

Retina Specialist, Towson

21209

COMPLETED

The Retina Care Center, Baltimore

21287

COMPLETED

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

21740

RECRUITING

Cumberland Valley Retina Consultants;Clinical Research, Hagerstown

23235

RECRUITING

Retina Institute of Virginia, Richmond

23502

COMPLETED

Wagner Kapoor Institute;Opthalmology, Norfolk

24502

COMPLETED

Piedmont Eye Center, Lynchburg

27705

COMPLETED

Duke Eye Center, Durham

28210

COMPLETED

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

28401

WITHDRAWN

Cape Fear Retinal Associates, Wilmington

28602

COMPLETED

Graystone Eye;Clinical Research, Hickory

28803

COMPLETED

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

29169

COMPLETED

Palmetto Retina Center, West Columbia

WITHDRAWN

Palmetto Retina Center, West Columbia

29456

COMPLETED

Charleston Neuroscience, Ladson

29464

COMPLETED

Carolina Eyecare Physicians, Mt. Pleasant

30060

COMPLETED

Georgia Retina, Marietta

30909

RECRUITING

Southeast Retina Center, Augusta

32308

WITHDRAWN

Southern Vitreoretinal Associates;Research, Tallahassee

32503

RECRUITING

Retina Specialty Institute, Pensacola

33308

COMPLETED

Retina Group of Florida, Fort Lauderdale

33324

RECRUITING

Fort Lauderdale Eye Institute, Plantation

33609

COMPLETED

Retina Associates of Florida;Retina Associates of Florida, Tampa

33711

RECRUITING

Retina Vitreous Associates of Florida, St. Petersburg

33912

COMPLETED

National Ophthalmic Research Institute, Fort Myers

37203

ACTIVE_NOT_RECRUITING

Tennessee Retina, Nashville

38138

WITHDRAWN

Charles Retina Institution;Retina surgery, Germantown

40509

COMPLETED

Retina & Vitreous Associates of Kentucky, Lexington

43016

COMPLETED

Midwest Retina;Retina/Vitreous, Dublin

43212

RECRUITING

Ohio State Havener Eye Institute;Ophthalmology Research, Columbus

44195

COMPLETED

Cleveland Clinic, Cleveland

45242

RECRUITING

Cincinnati Eye Institute;Retina, Cincinnati

48073

COMPLETED

Associated Retinal Consultants - Royal Oak, Royal Oak

49546

COMPLETED

Retina Specialists Of Michigan, Grand Rapids

50266

COMPLETED

Wolfe Eye Clinic, West Des Moines

55435

COMPLETED

VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota, Minneapolis

60435

COMPLETED

Illinois Retina Associates, Joliet

60439

COMPLETED

University Retina, Lemont

60611

COMPLETED

Northwestern Memorial Hospital, Chicago

63017

COMPLETED

Pepose Vision Institute, Chesterfield

63128

COMPLETED

Retina Institute, St Louis

66215

COMPLETED

Retina Associates, Lenexa

73013

COMPLETED

Retina Vitreous Center - Glen Eagles, Edmond

75231

COMPLETED

Texas Retina Associates;Research, Dallas

76012

COMPLETED

Texas Retina Associates, Arlington

76104

COMPLETED

Texas Retina Associates, Fort Worth

77401

WITHDRAWN

Retina & Vitreous of Texas, Bellaire

RECRUITING

Retina Consultants of Texas, Houston

78240

RECRUITING

Medical Center Ophthalmology Associates, San Antonio

78705

COMPLETED

Austin Research Center for Retina, Austin

COMPLETED

Austin Retina Associates;Opthalmology, Austin

78750

COMPLETED

Austin Clinical Research, LLC, Austin

79606

COMPLETED

Retina Research Institute of Texas, Abilene

80228

COMPLETED

Colorado Clinical Research, Lakewood

80528

COMPLETED

Eye Center of Northern Colorado, Fort Collins

84107

COMPLETED

Rocky Mountain Retina Consultants, Murray

COMPLETED

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

85014

COMPLETED

Retinal Consultants of Arizona;Opthalmology, Phoenix

85016

COMPLETED

Arizona Retina and Vitreous Consultants, Phoenix

85020

COMPLETED

Associated Retina Consultants, Phoenix

85206

COMPLETED

Barnet Dulaney Perkins Eye Center, Mesa

89502

RECRUITING

Sierra Eye Associates, Reno

90095

COMPLETED

Jules Stein Eye Institute/ UCLA, Los Angeles

90211

COMPLETED

Retina-Vitreous Associates Medical Group, Beverly Hills

91105

COMPLETED

Doheny Eye Institute, Pasadena

91107

COMPLETED

California Eye Specialists Medical Group, Pasadena

91436

COMPLETED

The Retina Partners, Encino

92705

RECRUITING

Orange County Retina Medical Group, Santa Ana

92835

RECRUITING

Retina Consultants of Orange County;Clinical Research, Fullerton

93103

COMPLETED

California Retina Consultants;Research Department, Santa Barbara

93309

RECRUITING

California Retina Consultants, Bakersfield

94040

COMPLETED

Northern California Retina-Vitreous Associates, Mountain View

94110

COMPLETED

Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco

94609

RECRUITING

East Bay Retina Consultants, Oakland

95841

RECRUITING

Retina Consultants Medical Group, Sacramento

97221

COMPLETED

Retina Northwest;Research Department, Portland

98383

COMPLETED

Pacific Northwest Retina, Silverdale

99204

RECRUITING

Spokane Eye Clinical Research;Spokane Eye Surgery Center, Spokane

06385

ACTIVE_NOT_RECRUITING

Retina Group of New England, Waterford

04605

ACTIVE_NOT_RECRUITING

Maine Eye Center, Portland

02111

ACTIVE_NOT_RECRUITING

Tufts Medical Center, Boston

02114

COMPLETED

Ophthalmic Consultants of Boston, Boston

01605

COMPLETED

Vitreo Retinal Associates, Worcester

07003

COMPLETED

Envision Ocular, LLC, Bloomfield

07666

ACTIVE_NOT_RECRUITING

Retina Associates of New Jersey, Teaneck

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY