A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

401

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Diabetic Macular Edema
Interventions
DRUG

Dexamethasone ophthalmic suspension (OCS-01)

Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

DRUG

Vehicle

Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

Trial Locations (62)

1023

Fundacion Zambrano, Buenos Aires

1663

Centro De Ojos Loria Srl, CABA

Centro Privado de Ojos, CABA

5000

Centro Privado de Ojos Romagosa, Córdoba

11195

Sibia Eye Institute, Boynton Beach

11590

Vitreoretinal Consultants of NY, Westbury

11788

VitreoRetinal Consultants of NY, Hauppauge

11967

Island Retina, Shirley

16507

Erie Retina Research, Erie

19141

Vision Research Solutions in Philadelphia, Philadelphia

21740

Cumberland Valley Retina Consultants, Hagerstown

Mid Atlantic Retina Specialists, Hagerstown

24502

Piedmont Eye Center, Lynchburg

29169

Palmetto Retina Center, West Columbia

30060

Marietta Eye Clinic, Marietta

30269

Georgia Retina, Peachtree City

32256

East Coast Institute for Research, Jacksonville

33067

Advanced Research, Coral Springs

33308

Retina Group of Florida, Fort Lauderdale

33761

Blue Ocean Clinical Research, Clearwater

33912

Retina Consultants of Southwest Florida, Naples

37203

Tennessee Retina, Nashville

38138

Charles Retina Institute, Germantown

60304

Illinois Retina Associates, Oak Park

75703

Tyler Retina Consultants, Tyler

76028

Star Retina, Burleson

77025

Houston Eye Associates, North Loop, Houston

77401

Retina Consultants of Texas, Bellaire

78215

San Antonio Eye Center - Downtown Clinic, San Antonio

78240

Medical Center Ophthalmology Associates, San Antonio

78681

Austin Retina Associates, Round Rock

80210

Retina Specialists of Colorado, Denver

80503

Eye Care Center of Northern Colorado, Longmont

85020

Associated Retina Consultants, Phoenix

85053

Retinal Consultants of Arizona - Phoenix North, Phoenix

85297

Associated Retina Consultants, Gilbert

89502

Sierra Eye Associates, Reno

90033

Mississippi Retina Associates, Jackson

90503

Macula Retina Vitreous Center, Torrance

92647

Retina Associates of Southern California, Huntington Beach

93103

California Retina Consultants, Santa Barbara

93309

California Retina Consultants, Bakersfield

94303

Stanford Byers Eye Institute, Palo Alto

95825

Retinal Consultants Medical Group, Inc, Sacramento

95841

Retinal Consultants Medical Group, Sacramento

208005

GSVM Medical College, Kanpur

302004

Agrawal Hospital, Jaipur

380015

Rising Retina Clinic, Ahmedabad

500038

St. Theresa's Hospital, Hyderabad

560010

Narayana Nethralaya, Bangalore

641014

Lotus Eye Hospital and Institute, Coimbatore

02114

Ophthalmic Consultants of Boston, Boston

C1120 AAN

Oftalmos - Instituto Oftalmológico de Alta Complejidad, Buenos Aires

C1015

Organizacion Medica De Investigacion, CABA

C1061AAE

Buenos Aires Macula (BAM) Clinical Research, CABA

C1008

Charles Centro Oftalmológico, Ciudad Autónoma de Buenos Aires

X5016KEH

Instituto de Microcirugía Ocular Córdoba (IMOC), Córdoba

M5500

Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital, Mendoza

A4400

Centro de la Vision Dr. Kolton, Salta

S2000 PRB

Grupo Laser Vision, Rosario

S2000

Oftalmologìa Global, Rosario

00612

Emanuelli Research & Development Center, Arecibo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Oculis

INDUSTRY

NCT06172257 - A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2) | Biotech Hunter | Biotech Hunter