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

PHASE3TerminatedINTERVENTIONAL
Enrollment

459

Participants

Timeline

Start Date

September 30, 2020

Primary Completion Date

April 27, 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 (72)

1085

Semmelweis Egyetem, Budapest

1106

Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

1133

Budapest Retina Associates Kft, Budapest

11572

Ophthalmic Consultants of Long Island, 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

20132

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

21079

CHRU Dijon Complexe Du Bocage, Dijon

23235

Retina Institute of Virginia, Richmond

28803

Asheville Eye Associates, Asheville

30060

Georgia Retina, P.C., Marietta

30909

Southeast Retina Center, Augusta

31048

Bnai Zion, Haifa

31096

Rambam MC, Haifa

32308

Southern Vitreoretinal Associates, Tallahassee

33064

Rand Eye Institute, Deerfield Beach

33324

Fort Lauderdale Eye Institute, Plantation

33426

Florida Eye Microsurgical Institute, Boynton Beach

33703

Retina Vitreous Associates of Florida, St. Petersburg

33912

National Ophthalmic Research Institute, Fort Myers

37922

Southeastern Retina Associates PC, Knoxville

44195

Cleveland Clinic Foundation, Cole Eye Institute, Cleveland

44281

Meir MC, Kfar Saba

47710

Talley Eye, Evansville

48073

Associated Retinal Consultants PC, Royal Oak

49100

Rabin Medical Center, Petah Tikva

53002

OFTEX s.r.o., Pardubice

55435

Vitreoretinal Surgery PA, Minneapolis

69317

Hôpital de La Croix Rousse, Lyon

70300

Shamir Medical Center Assaf Harofeh, Tzrifin

75019

Fondation Rothschild, Paris

75075

Texas Retina Associates, Plano

76100

Kaplan MC, Rehovot

76108

Texas Retina Associates, Fort Worth

77384

Retina Consultants of Houston - (Woodlands), The Woodlands

77494

Retina Consultants of Houston-(Katy), Katy

78240

Medical Center Ophthalmology Associates, San Antonio

78681

Austin Retina Associates (Round Rock), Round Rock

78705

Austin Research Center for Retina, Austin

79606

Retina Research Institute of Texas, Abilene

80131

AOU dell'Università degli Studi della Campania Luigi Vanvitelli, Naples

83713

Retina Specialists of Idaho, Boise

85014

Retinal Research Institute, LLC, Phoenix

89052

Retina Consultants of NV, Henderson

89502

Sierra Eye Associates, Reno

90211

Retina Vitreous Associates, Beverly Hills

91120

Hadassah University Hospital, Jerusalem

92064

Retina Consultants of San Diego, Poway

92835

Retina Consultants of Orange County, Fullerton

94000

Centre Hospitalier Intercommunal de Créteil, Créteil

94040

Northern California Retina Vitreous Associates, Mountain View

95825

Retinal Consultants Medical Group Inc, Sacramento

96701

Retina Consultants of Hawaii, Inc, ‘Aiea

97302

Retina Consultants, LLC, Salem

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

6789140

Assuta HaShalom, Tel Aviv

06385

Retina Group of New England, Waterford

04101

Maine Eye Center, Portland

128 08

Vseobecna Fakultni, Prague

150 00

Lekarna BENU, Prague

75 010

Hôpital Lariboisière - Service Pharmacie , Essais cliniques - Aude Jacob, Paris

H-4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház, Nyíregyháza

00168

Fondazione Policlinico Universitario A Gemelli, Rome

80-809

Optimum Profesorskie Centrum Okulistyki, Gdansk

40-514

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

85-631

Oftalmika Sp. z o.o., Bydgoszcz

01-249

Dr Nowosielska Okulistyka i Chirurgia Oka, Warsaw

58-309

Specjalistyczny Szpital im. Alfreda Sokolowskiego, Wałbrzych

50-556

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

00612

Emanuelli Research & Development Center LLC, Arecibo

Sponsors
All Listed Sponsors
lead

Kodiak Sciences Inc

INDUSTRY

NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) | Biotech Hunter | Biotech Hunter