A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

October 19, 2021

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Diabetic Macular Edema
Interventions
DRUG

Dexamethasone ophthalmic suspension (OCS-01)

"Stage 1: 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 6 weeks (maintenance phase).~Stage 2: 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

"Stage 1: 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 6 weeks (maintenance phase).~Stage 2: Participant 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 (52)

500

Changhua Christian Hospital, Changhua

11217

Taipei Veterans General Hospital, Taipei

13088

Retina-Vitreous Surgeons of Central New York, Liverpool

19141

Vision Research Solutions in Philadelphia, Philadelphia

21740

Cumberland Valley Retina Consultants, Hagerstown

24502

Piedmont Eye Center, Lynchburg

27587

North Carolina Retina Associates, Wake Forest

29456

Charleston Neuroscience Institute, Ladson

29902

Retina Consultants of Charleston, Beaufort

30909

Southeast Retina Center, Augusta

32216

Florida Retina Institute, Jacksonville

32806

Florida Retina Institute, Orlando

33064

Rand Eye Institute, Deerfield Beach

33143

MedEye Associates, Miami

33305

Chang Gung Memorial Hospital, Taoyuan District

33410

Retina Care Specialists, Palm Beach Gardens

34994

East Florida Eye Institute, Stuart

40447

China Medical University Hospital, Taichung

45202

Velocity (Meridian) Clinical Research, Cincinnati

46290

Midwest Eye Institute, Carmel

55416

Retina Consultants of Minnesota, Saint Louis Park

57701

Black Hills Regional Eye Institute, Rapid City

60126

Retina Associates, Elmhurst

60439

University Retina, Lemont

63128

The Retina Institute, St Louis

72764

Retina Partners of Northwest Arkansas, Springdale

75231

Texas Retina Associates, Dallas

75703

Tyler Retina Consultants, Tyler

76051

Retina Center of Texas, Grapevine

76087

Strategic Clinical Research Group, Willow Park

78503

Valley Retina Institute PA d.b.a. Gulf Coast Eye Institute, McAllen

78705

Retina Consultants of Austin/Austin Research Center for Retina, Austin

79606

Retina Research Institute of Texas, Abilene

85016

Arizona Retina and Vitreous Consultants, Phoenix

85050

Phoenix Retina Associates, Phoenix

90211

Retina-Vitreous Associates Medical Group, Beverly Hills

91107

California Eye Specialists Medical Group, Pasadena

91436

The Retina Partners, Encino

92373

California Eye Specialists Medical Group, Redlands

92374

Retina Consultants of Southern California, Redlands

93454

California Retina Consultants, Santa Maria

95356

Retinal Consultants Medical Group, Modesto

97401

Verum Research LLC, Eugene

201301

ICARE Eye Hospital & Post Graduate Institute, Noida

395001

Shivam Retina Clinic and Eye Hospital, Surat

440025

Sarakshi Netralaya, Nagpur

560094

Nethra Eye Hospital, Bengaluru

682041

Amrita Institute of Medical Sciences & Research Centre, Kochi

751024

L V Prasad Eye Institute, Bhubaneswar

06385

Retina Group Of New England, Waterford

Unknown

HKU Eye Centre, Hong Kong

Chinese University of Hong Kong Eye Centre, Kowloon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Oculis

INDUSTRY