A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

PHASE2CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

July 31, 2020

Primary Completion Date

September 28, 2023

Study Completion Date

November 22, 2023

Conditions
Diabetes MellitusDiabetic RetinopathyDiabetic Macular Edema
Interventions
DRUG

THR-149 dose level 1

3 intravitreal injections of THR-149 dose level 1, 1 month apart

DRUG

THR-149 dose level 2

3 intravitreal injections of THR-149 dose level 2, 1 month apart

DRUG

THR-149 dose level 3

3 intravitreal injections of THR-149 dose level 3, 1 month apart

DRUG

THR-149 0.13mg

3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection

DRUG

THR-149 0.13mg + aflibercept 2mg

3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg

DRUG

aflibercept 2mg + THR-149 0.13mg

3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)

DRUG

Aflibercept 2mg

3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection

Trial Locations (78)

8195

Hospital General de Catalunya, Barcelona

12800

Všeobecná fakultní nemocnice v Praze, Prague

13088

Retina-Vitreous Surgeons of Central New York, PC, Liverpool

14012

METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa), Córdoba

15706

Instituto Oftalmológico Gómez-Ulla, Santiago de Compostela

20132

IRCCS Ospedale San Raffaele, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

21740

Cumberland Valley Retina Consultants, Hagerstown

23502

Wagner Macula & Retina Center, Norfolk

24502

Piedmont Eye Center, Lynchburg

26505

WVU Eye Institute, Morgantown

27560

Retina Associates of Utah, Salt Lake City

28222

Hospital Universitario Puerta de Hierro Majadahonda, Madrid

30060

Marietta Eye Clinic, Marietta

30909

Southeast Retina Center, Augusta

33143

MedEye Associates, South Miami

33324

Fort Lauderdale Eye Institute, Plantation

33761

Blue Ocean Clinical Research, Clearwater

33880

Center for Retina and Macular Disease, Winter Haven

37075

Universitätsmedizin Göttingen, Göttingen

37203

Tenneesse Retina, Nashville

40549

Internationale Innovative Ophthalmochirurgie, Düsseldorf

41009

Hospital Universitario Virgen Macarena, Seville

44106

University Hospitals Cleveland Medical Center, Cleveland

44122

Retina Associates of Cleveland, Inc, Cleveland

45242

Cincinnati Eye Institute, Cincinnati

46015

Fundación de Oftalmología Médica de la Comunitat Valenciana, Valencia

47012

Hospital Universitario Rio Hortega, Valladolid

48202

Henry Ford Hospital, Detroit

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

60452

University Retina and Macula Associates, PC, Oak Forest

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

75019

Fondation Rothschild, Paris

75231

Texas Retina Associates, Dallas

75475

Hôpital Lariboisière, Paris

77025

Houston Eye Associates, Houston

77030

Retina Consultants of Houston, PA, Houston

78240

Medical Center Ophthalmology Associates, San Antonio

Retina Associates of South Texas, P.A., San Antonio

Retina Consultants of Texas, San Antonio

78503

Valley Retina Institute, PA, McAllen

78705

Austin Research Center for Retina, Austin

Austin Retina Associates, Austin

Retina Research Center, PLLC, Austin

79606

Retina Research Institute of Texas, Abilene

80909

Retina Consultants of Southern Colorado, P.C., Colorado Springs

85053

Retinal Research Institute, LLC, Phoenix

85704

Retina Associates, Tucson

89502

Sierra Eye Associates, Reno

90211

Retina-Vitreous Associates Medical Group, Beverly Hills

92064

Retina Consultants San Diego, Poway

92647

Salehi Retina Institute Inc., Huntington Beach

93036

California Retina Consultants, Oxnard

93053

Universitätsklinikum Regensburg, Regensburg

94010

Centre Hospitalier Intercommunal de Créteil, Créteil

94040

Northern California Retina Vitreous Associates Medical Group, Inc., Mountain View

95825

Retinal Consultants Medical Group, Sacramento

97401

Sterling Vision, P.C. dba Oregon Retina, Eugene

480006

Instituto Clínico Quirúrgico de Oftalmología, Bilbao

02215

Joslin Diabetes Center, Boston

Unknown

CHU de Dijon, Dijon

Hôpital de la Croix Rousse, Lyon

Centre Paradis Monticelli, Marseille

Azienda Sanitaria Universitaria Friuli Centrale, Udine

Hospital Dos de Maig, Barcelona

01307

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

00184

IRCCS Fondazione G.B. Bietti, Roma

012 07

Fakultná nemocnica s poliklinikou Žilina, Žilina

08024

Hospital de la Esperanza, Barcelona

08907

Hospital Universitari de Bellvitge, Barcelona

BS1 2LX

University Hospitals Bristol NHS Foundation Trust, Bristol

CT1 3NG

Kent and Canterbury Hospital, Canterbury

GU16 7UJ

Frimley Health NHS Foundation Trust, Frimley

EC1V 2PD

Moorfields Eye Hospital NHS Foundation Trust, London

NW10 7NS

London North West University Healthcare NHS Trust, London

SE5 9RS

King's College Hospital NHS Foundation Trust, London

SR2 9HP

South Tyneside and Sunderland NHS Foundation Trust, Sunderland

SS0 ORY

Mid and South Essex NHS Foundation Trust, Westcliff-on-Sea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Oxurion

INDUSTRY