A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

PHASE3TerminatedINTERVENTIONAL
Enrollment

460

Participants

Timeline

Start Date

September 30, 2020

Primary Completion Date

May 11, 2023

Study Completion Date

August 31, 2023

Conditions
Diabetic Macular Edema
Interventions
DRUG

KSI-301

Intravitreal Injection

DRUG

Aflibercept

Intravitreal Injection

OTHER

Sham Procedure

The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

Trial Locations (75)

1214

Jahn Ferenc Dél-Pesti Kórház és Rendelointézet, Budapest

7621

Ganglion Medical Center, Pécs

17036

Dietrich Bonhoeffer Klinikum Neubrandenburg, Neubrandenburg

19107

MidAtlantic Retina, Philadelphia

21740

Cumberland Valley Retina Consultants PC, Hagerstown

24502

Piedmont Eye Center, Lynchburg

28210

Charlotte Eye Ear Nose & Throat Associates, P.A., Charlotte

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Madrid

29169

Palmetto Retina Center, West Columbia

29414

Charleston Neuroscience Institute - West Ashley, Charleston

29456

Charleston Neuroscience Institute, Ladson

29501

Pametto Retina Center, Florence

29902

Retina Research of Beaufort, Beaufort

32503

Retina Specialty Institute, Pensacola

32607

Vitreo Retinal Associates, Gainesville

32806

Florida Retina Institute, Orlando

32901

Florida Eye Associates, Melbourne

33431

Retina Group of Florida, Boca Raton

33609

Retina Associates of Florida, Tampa

33617

Retina Vitreous Associates of Florida, Tampa

33761

Blue Ocean Clinical Research, Clearwater

33805

Florida Retina Consultants, Lakeland

33880

Center for Retina & Macular Disease, Winter Haven

37203

Tennessee Retina PC, Nashville

38138

Charles Retina Institute, Germantown

40509

Retina Associates of Kentucky, Lexington

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

47012

Hospital Universitario Rio Hortega, Valladolid

48145

St Franziskus Hospital, Münster

49525

Foundation for Vision Research, Grand Rapids

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

Hospital Universitario Miguel Servet, Zaragoza

50266

Wolfe Eye Clinic, West Des Moines

50935

St. Elisabeth Krankenhaus, Cologne

57701

Black Hills Regional Eye Institute, Rapid City

62703

Springfield Clinic LLP, Springfield

66215

Retina Associates PA, Lenexa

67214

Vitreo Retinal Consultants and Surgeons, Wichita

76012

Texas Retina Associates, Arlington

76028

Star Retina, Burleson

76087

Strategic Clinical Research Group, LLC, Willow Park

77030

Retina Consultants of Texas, Houston

78240

Retina Consultants of San Antonio, San Antonio

78705

Austin Retina Associates, Austin

79106

Southwest Retina Specialists, Amarillo

Universitätsklinikum Freiburg, Freiburg im Breisgau

80228

Colorado Retina Associates PC, Lakewood

90502

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

92037

UCSD Jacobs Retina Center, La Jolla

92374

Retina Consultants of Southern California, Redlands

93053

Universitätsklinikum Regensburg, Regensburg

93454

California Retina Consultants, Santa Maria

97210

Retina Northwest, Portland

97477

Cascade Medical Research Institute, Springfield

98383

Retina Center Northwest, Silverdale

99204

Spokane Eye, Spokane

06810

Conneticut Eye Consultants, Danbury

02114

Ophthalmic Consultants of Boston, Boston

07017

The Retina Center of New Jersey, Bloomfield

07605

NJ Retina, Teaneck

00133

Fondazione PTV Policlinico Tor Vergata, Roma

LV-3001

Signes Ozolinas Doctor Praxis In Ophthalmology, Jelgava

LV-1002

Pauls Stradins Clinical University Hospital, Riga

LV-1006

Riga Eastern Clinical University Hospital Clinic Bikernieki, Riga

LV-1009

Latvian American Eye Center, Riga

00612

Emanuelli Research & Development Center LLC, Arecibo

974 01

Fakultna nemocnica s poliklinikou F. D. Roosevelta, Banská Bystrica

826 06

Univerzitna nemocnica Bratislava, Bratislava

036 01

Uvea Klinika, S.R.O., Martin

075 01

Nemocnica s poliklinikou Trebisov a.s. Ocne oddelenie - jednonova zdravotna starostlivost, Trebišov

911 01

Fakultna nemocnica Trencin, Trencín

012 07

Fakultna nemocnica s poliklinikou Zilina, Žilina

08025

Hospital dos de Maig, Barcelona

08028

Hospital Clinic de Barcelona, Barcelona

08195

Hospital Universitari General de Catalunya - Grupo Quironsalud, Barcelona

Sponsors
All Listed Sponsors
lead

Kodiak Sciences Inc

INDUSTRY

NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) | Biotech Hunter | Biotech Hunter