A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

PHASE3CompletedINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

September 25, 2020

Primary Completion Date

June 10, 2022

Study Completion Date

January 19, 2023

Conditions
Macular EdemaRetinal Vein Occlusion
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 (141)

1062

MH EK Honvedkorhaz SzemEszeti Osztaly, Budapest

1085

Semmelweis Egyetem, Budapest

1106

Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

1133

Budapest Retina Associates Kft, Budapest

1214

Jahn Ferenc Dél-Pesti Kórház és Rendelointézet, Budapest

11572

Ocli Vision, Oceanside

11788

Vitreo Retinal Consultants, Hauppauge

13008

Centre Paradis Monticelli, Marseille

13088

Retina-Vitreous Surgeons of Central NY, Liverpool

14620

Retina Associates of Western NY, Rochester

17036

Dietrich Bonhoeffer Klinikum Neubrandenburg, Neubrandenburg

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

20815

Retina Group of Washington, Chevy Chase

21079

CHRU Dijon Complexe Du Bocage, Dijon

21740

Cumberland Valley Retina Consultants PC, Hagerstown

23235

Retina Institute of Virginia, Richmond

28210

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

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda

28803

Asheville Eye Associates, Asheville

29456

Charleston Neuroscience Institute, Ladson

29501

Pametto Retina Center, West Columbia

29605

Retina Consultants of Carolina, Greenville

29902

Retina Research of Beaufort, Beaufort

30909

Southeast Retina Center, Augusta

31048

Bnai Zion, Haifa

31096

Rambam MC, Haifa

32308

Southern Vitreoretinal Associates, Tallahassee

32503

Retina Specialty Institute, Pensacola

32607

Vitreo Retinal Associates, Gainesville

32701

Florida Eye Clinic, Altamonte Springs

32806

Florida Retina Institute, Orlando

32901

Florida Eye Associates, Melbourne

33064

Rand Eye Institute, Deerfield Beach

33076

Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin, Bordeaux

33100

Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia, Udine

33324

Fort Lauderdale Eye Institute, Plantation

33426

Florida Eye Microsurgical Institute, Boynton Beach

33431

Retina Group of Florida, Boca Raton

33609

Retina Associates of Florida, Tampa

33761

The Macula Center/ Blue Ocean Clinical Research, Clearwater

33880

Center for Retina & Macular Disease, Winter Haven

33912

National Ophthalmic Research Institute, Fort Myers

37203

Tennessee Retina PC, Nashville

37909

Southeastern Retina Associates PC, Knoxville

38138

Charles Retina Institute, Germantown

40509

Retina Associates of Kentucky, Lexington

44122

Retina Associates of Cleveland, Beachwood

44130

Retina Associates of Cleveland, Cleveland

44281

Meir MC, Kfar Saba

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

47012

Hospital Universitario Rio Hortega, Valladolid

47710

Talley Eye, Evansville

48010

Instituto Clinico Quirurgico de Oftalmologia, Bilbao

48145

Miriam Kannenbaeumer or Andrea Koschinski, Münster

49100

Rabin Medical Center, Petah Tikva

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

53002

OFTEX s.r.o., Pardubice

55435

Vitreoretinal Surgery PA, Edina

57701

Black Hills Regional Eye Institute, Rapid City

62703

Springfield Clinic LLP, Springfield

66100

Ospedale Clinicizzato SS Annunziata, Chieti

66215

Retina Associates PA, Lenexa

67214

Vitreo Retinal Consultants and Surgeons, Wichita

69317

Hôpital de La Croix Rousse, Lyon

70300

Shamir Medical Center Assaf Harofeh, Tzrifin

75019

Fondation Rothschild, Paris

75075

Texas Retina Associates, Plano

76087

Strategic Clinical Research Group, LLC, Willow Park

76100

Kaplan MC, Rehovot

77030

Retina Consultants of Texas, Houston

77384

Retina Consultants of Texas - (Woodlands), The Woodlands

77494

Retina Consultants of Texas - (Katy), Katy

78073

Associated Retinal Consultants PC, Royal Oak

78240

Medical Center Ophthalmology Associates, San Antonio

78681

Austin Retina Associates (Round Rock), Round Rock

78705

Austin Research Center for Retina, Austin

Austin Retina Associates, Austin

Retina Research Center, Austin

79606

Retina Research Institute of Texas, Abilene

80228

Colorado Retina Associates PC, Lakewood

85014

Northwest Arkansas Retina Associates, Phoenix

Retinal Research Institute, LLC, Phoenix

86021

CHRU de Poitiers La Miletrie, Poitiers

89052

Retina Consultants of NV, Henderson

89502

Sierra Eye Associates, Reno

90211

Retina Vitreous Associates, Beverly Hills

91120

Hadassah University Hospital, Jerusalem

92037

UCSD Jacobs Retina Center, La Jolla

92064

Retina Consultants of San Diego, Poway

92374

Retina Consultants of Southern California, Redlands

92705

Orange County Retina Medical Group, Santa Ana

92835

Retina Consultants of Orange County, Fullerton

93053

Universitätsklinikum Regensburg, Regensburg

93454

California Retina Consultants, Santa Maria

93720

Eye Medical Center of Fresno, Fresno

94000

Centre Hospitalier Intercommunal de Créteil, Créteil

94040

Northern California Retina Vitreous Associates, Mountain View

95819

Retinal Consultants Medical Group Inc, Sacramento

97210

Retina Northwest, Portland

97302

Retina Consultants, LLC, Salem

97477

Cascade Medical Research Institute, Springfield

98383

Retina Center Northwest, Silverdale

99204

Spokane Eye, Spokane

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

6789140

Assuta HaShalom, Tel Aviv

06810

Conneticut Eye Consultants, Danbury

06385

Retina Group of New England, Waterford

04102

Maine Eye Center, Portland

02114

Ophthalmic Consultants of Boston, Boston

01603

Vitreo Retinal Associates PC, Worcester

07017

The Retina Center of New Jersey, Bloomfield

07605

NJ Retina, Teaneck

128 08

Vseobecna Fakultni, Prague

150 00

Lekarna BENU, Prague

75 010

Hôpital Lariboisière - Service Pharmacie, Paris

00133

Fondazione PTV Policlinico Tor Vergata, Rome

00168

Fondazione Policlinico Universitario A Gemelli, Rome

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

80-809

Optimum Profesorskie Centrum Okulistyki, Gdansk

40-514

Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi, Katowice

40-594

Gabinet Okulistyczny Prof. Edward Wylegala, Katowice

85-631

Oftalmika Sp. z o.o., Bydgoszcz

01-249

Dr Nowosielska Okulistyka i Chirurgia Oka, Warsaw

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

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., Trebišov

911 01

Fakultna nemocnica Trencin, Trencín

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08195

Hospital Universitari General de Catalunya - Grupo Quironsalud, Sant Cugat del Vallès

08025

Hospital dos de Maig, Barcelona

08028

Hospital Clinic de Barcelona, Barcelona

Sponsors
All Listed Sponsors
lead

Kodiak Sciences Inc

INDUSTRY