A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

PHASE2/PHASE3TerminatedINTERVENTIONAL
Enrollment

559

Participants

Timeline

Start Date

October 8, 2019

Primary Completion Date

November 17, 2021

Study Completion Date

April 26, 2022

Conditions
Wet Macular Degeneration
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)

1002

Pauls Stradins Clinical University Hospital, Riga

1038

Riga Eastern Clinical University Hospital Clinic Bikernieki, Riga

19107

Wills Eye Hospital, Philadelphia

21740

Cumberland Valley Retina Consultants PC, Hagerstown

29456

Charleston Neuroscience Institute, Ladson

29501

Palmetto Retina Center, Florence

30625

Medizinische Hochschule Hannover, Hanover

30909

Southeast Retina Center, Augusta

32503

Retina Specialty Institute, Pensacola

32901

Florida Eye Associates, Melbourne

33064

Rand Eye Institute, Deerfield Beach

33426

Florida Eye Microsurgical Institute, Boynton Beach

33609

Retina Associates of Florida, Tampa

33703

Retina Vitreous Associates of Florida, St. Petersburg

33907

Retina Health Center, Fort Myers

33912

National Ophthalmic Research Institute, Fort Myers

37203

Tennessee Retina PC, Nashville

37909

Southeastern Retina Associates PC, Knoxville

40509

Retina Associates of Kentucky, Lexington

44122

Retina Associates of Cleveland, Beachwood

44130

Retina Associates of Cleveland, Cleveland

44195

Cleveland Clinic Foundation, Cole Eye Institute, Cleveland

49525

Foundation for Vision Research, Grand Rapids

50266

Wolfe Eye Clinic, West Des Moines

50937

Uniklinik Köln, Cologne

53127

Universitätsklinikum Bonn, Bonn

55435

Vitreoretinal Surgery PA, Edina

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

72762

Northwest Arkansas Retina Associates, Springdale

75075

Texas Retina Associates, Plano

76087

Strategic Clinical Research Group, LLC, Willow Park

77384

Retina Consultants of Texas (Woodlands), The Woodlands

77401

Retina Consultants of Texas, Bellaire

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 Clinical Research, LLC, Austin

Austin Retina Associates, Austin

79606

Retina Research Institute of Texas, Abilene

80228

Colorado Retina Associates PC, Lakewood

85014

Retinal Research Institute, LLC, Phoenix

89502

Sierra Eye Associates, Reno

90211

Retina Vitreous Associates, Beverly Hills

92037

UCSD Jacobs Retina Center, La Jolla

92064

Retina Consultants of San Diego, Poway

92653

Retina Associates of Orange County, Laguna Hills

92705

Orange County Retina Medical Group, Santa Ana

92835

Retina Consultants of Orange County, Fullerton

93309

California Retina Consultants, Bakersfield

93454

California Retina Consultants, Santa Maria

93720

Eye Medical Center of Fresno, Fresno

94040

Northern California Retina Vitreous Associates, Mountain View

95819

Retinal Consultants Medical Group Inc, Sacramento

97210

Retina Northwest, Portland

97401

Cascade Medical Research Institute, Eugene

97520

Retina and Vitreous Center of Southern Oregon PC, Ashland

01103

New England Retina Consultants, Springfield

01603

Vitreo Retinal Associates PC, Worcester

07017

The Retina Center of New Jersey, Bloomfield

07605

NJ Retina, Teaneck

150 00

Axon Clinical, s.r.o., Prague

04103

Universitatsklinikum Leipzig, Leipzig

85-631

Oftalmika Sp. z o.o., Bydgoszcz

40-760

Gabinet Okulistyczny prof. E. Wylegala, Katowice

01-364

Retina Okulistyka Sp. z o.o. Sp. km., Warsaw

821 01

Univerzitna nemocnica Bratislava, Bratislava

075 01

Nemocnica Trebisov - SVET ZDRAVIA - PPDS, Trebišov

911 01

Fakultna nemocnica Trencin, Trenčín

012 07

Fakultna nemocnica s poliklinikou Zilina, Žilina

08022

Institut de La Macula i La Retina, Barcelona

08025

Hospital dos de Maig, Barcelona

Sponsors
All Listed Sponsors
lead

Kodiak Sciences Inc

INDUSTRY

NCT04049266 - A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. | Biotech Hunter | Biotech Hunter