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

NCT05066997 | Completed Phase 2 FDA Drug

• 1 other identifier: DX219
• Study Type: interventional
• Target: 552
• Locations: 4 countries
• Sites: 52

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS- 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).

Conditions

Diabetic Macular Edema

Keywords

Topical ophthalmic suspension; Eye drop

Outcome Measures

Primary Outcomes (1)

• Mean Change in BCVA (Best Corrected Visual Acuity)

  Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity

  Week 52

Secondary Outcomes (3)

• Percentage of Participants with a 3-line or Greater Gain in BCVA

  Baseline, Week 52

• Mean Change in BCVA

  Baseline, Week 12 and Week 24

• Mean Change in Central Subfield Thickness (CST)

  Baseline, Week 52

Other Outcomes (1)

• Number of Participants With Treatment Emergent Adverse events (TEAEs)

  Up to Week 52

Study Arms (2)

OCS-01

EXPERIMENTAL

dexamethasone ophthalmic suspension,1.5% \[15 mg/ mL\]

Drug: Dexamethasone ophthalmic suspension (OCS-01)

Vehicle Vehicle

PLACEBO COMPARATOR

Placebo is a Vehicle ophthalmic suspension of OCS-01

Drug: Vehicle

Interventions

Vehicle DRUG

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).

Also known as: Placebo

Vehicle Vehicle

Dexamethasone ophthalmic suspension (OCS-01) DRUG

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).

Also known as: Dexamethasone

OCS-01

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a signed informed consent form before any study-specific procedures are performed.
• Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
• Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening).
• Have a signed informed consent form before any study-specific procedures are performed.
• Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
• Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening).

You may not qualify if:

• Have macular edema considered to be because of a cause other than DME.
• Have a decrease in BCVA because of causes other than DME.
• Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Sponsors & Collaborators

• Oculis: lead

Study Sites (52)

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, 85016, United States

Location

Phoenix Retina Associates

Phoenix, Arizona, 85050, United States

Location

Retina Partners of Northwest Arkansas

Springdale, Arkansas, 72764, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Retinal Consultants Medical Group

Modesto, California, 95356, United States

Location

California Eye Specialists Medical Group

Pasadena, California, 91107, United States

Location

California Eye Specialists Medical Group

Redlands, California, 92373, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

Retina Group Of New England

Waterford, Connecticut, 06385, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Florida Retina Institute

Jacksonville, Florida, 32216, United States

Location

MedEye Associates

Miami, Florida, 33143, United States

Location

Florida Retina Institute

Orlando, Florida, 32806, United States

Location

Retina Care Specialists

Palm Beach Gardens, Florida, 33410, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Retina Associates

Elmhurst, Illinois, 60126, United States

Location

University Retina

Lemont, Illinois, 60439, United States

Location

Midwest Eye Institute

Carmel, Indiana, 46290, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Retina Consultants of Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Retina-Vitreous Surgeons of Central New York

Liverpool, New York, 13088, United States

Location

North Carolina Retina Associates

Wake Forest, North Carolina, 27587, United States

Location

Velocity (Meridian) Clinical Research

Cincinnati, Ohio, 45202, United States

Location

Verum Research LLC

Eugene, Oregon, 97401, United States

Location

Vision Research Solutions in Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

Retina Consultants of Charleston

Beaufort, South Carolina, 29902, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Retina Consultants of Austin/Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Center of Texas

Grapevine, Texas, 76051, United States

Location

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

McAllen, Texas, 78503, United States

Location

Tyler Retina Consultants

Tyler, Texas, 75703, United States

Location

Strategic Clinical Research Group

Willow Park, Texas, 76087, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

HKU Eye Centre

Hong Kong, Hong Kong

Location

Chinese University of Hong Kong Eye Centre

Kowloon, Hong Kong

Location

Shivam Retina Clinic and Eye Hospital

Surat, Gujarat, 395001, India

Location

Nethra Eye Hospital

Bengaluru, Karnataka, 560094, India

Location

Amrita Institute of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

Sarakshi Netralaya

Nagpur, Maharashtra, 440025, India

Location

L V Prasad Eye Institute

Bhubaneswar, Odisha, 751024, India

Location

ICARE Eye Hospital & Post Graduate Institute

Noida, Uttar Pradesh, 201301, India

Location

Changhua Christian Hospital

Changhua, Changhua, 500, Taiwan

Location

China Medical University Hospital

Taichung, Taichung, 40447, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan, Taoyuan, 33305, Taiwan

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Veeral S Sheth, MD

  University Retina - Lemont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: October 4, 2021
• Study Start: October 19, 2021
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6); HK (2); US (40); TW (4)