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

NCT06172257 | Completed Phase 3 FDA Drug

• 1 other identifier: DX221
• Study Type: interventional
• Target: 401
• Locations: 4 countries
• Sites: 62

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 from Baseline 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 ophthalmic suspension

PLACEBO COMPARATOR

Vehicle of OCS-01

Drug: Vehicle

Interventions

Dexamethasone ophthalmic suspension (OCS-01) DRUG

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

Vehicle DRUG

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).

Also known as: Placebo

Vehicle ophthalmic suspension

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 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 screening (Visit 1).

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 (62)

Associated Retina Consultants

Gilbert, Arizona, 85297, United States

Location

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Retinal Consultants of Arizona - Phoenix North

Phoenix, Arizona, 85053, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina Associates of Southern California

Huntington Beach, California, 92647, United States

Location

Stanford Byers Eye Institute

Palo Alto, California, 94303, United States

Location

Retinal Consultants Medical Group, Inc

Sacramento, California, 95825, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95841, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Macula Retina Vitreous Center

Torrance, California, 90503, United States

Location

Retina Specialists of Colorado

Denver, Colorado, 80210, United States

Location

Eye Care Center of Northern Colorado

Longmont, Colorado, 80503, United States

Location

Sibia Eye Institute

Boynton Beach, Florida, 11195, United States

Location

Blue Ocean Clinical Research

Clearwater, Florida, 33761, United States

Location

Advanced Research

Coral Springs, Florida, 33067, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32256, United States

Location

Retina Consultants of Southwest Florida

Naples, Florida, 33912, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Georgia Retina

Peachtree City, Georgia, 30269, United States

Location

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Mississippi Retina Associates

Jackson, Mississippi, 90033, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

VitreoRetinal Consultants of NY

Hauppauge, New York, 11788, United States

Location

Island Retina

Shirley, New York, 11967, United States

Location

Vitreoretinal Consultants of NY

Westbury, New York, 11590, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Vision Research Solutions in Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Star Retina

Burleson, Texas, 76028, United States

Location

Houston Eye Associates, North Loop

Houston, Texas, 77025, United States

Location

Austin Retina Associates

Round Rock, Texas, 78681, United States

Location

San Antonio Eye Center - Downtown Clinic

San Antonio, Texas, 78215, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Tyler Retina Consultants

Tyler, Texas, 75703, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Fundacion Zambrano

Buenos Aires, Buenos Aires, 1023, Argentina

Location

Oftalmos - Instituto Oftalmológico de Alta Complejidad

Buenos Aires, Buenos Aires, C1120 AAN, Argentina

Location

Centro De Ojos Loria Srl

CABA, Buenos Aires, 1663, Argentina

Location

Centro Privado de Ojos

CABA, Buenos Aires, 1663, Argentina

Location

Organizacion Medica De Investigacion

CABA, Buenos Aires, C1015, Argentina

Location

Buenos Aires Macula (BAM) Clinical Research

CABA, Buenos Aires, C1061AAE, Argentina

Location

Charles Centro Oftalmológico

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1008, Argentina

Location

Centro Privado de Ojos Romagosa

Córdoba, Córdoba Province, 5000, Argentina

Location

Instituto de Microcirugía Ocular Córdoba (IMOC)

Córdoba, Córdoba Province, X5016KEH, Argentina

Location

Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital

Mendoza, Mendoza Province, M5500, Argentina

Location

Centro de la Vision Dr. Kolton

Salta, Salta Province, A4400, Argentina

Location

Grupo Laser Vision

Rosario, Santa Fe Province, S2000 PRB, Argentina

Location

Oftalmologìa Global

Rosario, Santa Fe Province, S2000, Argentina

Location

Rising Retina Clinic

Ahmedabad, Gujarat, 380015, India

Location

Narayana Nethralaya

Bangalore, Karnataka, 560010, India

Location

Agrawal Hospital

Jaipur, Rajasthan, 302004, India

Location

Lotus Eye Hospital and Institute

Coimbatore, Tamil Nadu, 641014, India

Location

St. Theresa's Hospital

Hyderabad, Telangana, 500038, India

Location

GSVM Medical College

Kanpur, Uttar Pradesh, 208005, India

Location

Emanuelli Research & Development Center

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Diana Do, MD

  Stanford Byers Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: March 15, 2024
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6); PR (1); US (42); AR (13)