ACTIVE_NOT_RECRUITING

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

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Conditions

Diabetic Macular EdemaTopical ophthalmic suspensionEye drop

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema

Quick Facts

Study Start:2024-03-15
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06172257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Diana Do, MD
PRINCIPAL_INVESTIGATOR
Stanford Byers Eye Institute

Study Locations (Sites)

Associated Retina Consultants
Gilbert, Arizona, 85297
United States
Associated Retina Consultants
Phoenix, Arizona, 85020
United States
Retinal Consultants of Arizona - Phoenix North
Phoenix, Arizona, 85053
United States
California Retina Consultants
Bakersfield, California, 93309
United States
Retina Associates of Southern California
Huntington Beach, California, 92647
United States
Stanford Byers Eye Institute
Palo Alto, California, 94303
United States
Retinal Consultants Medical Group, Inc
Sacramento, California, 95825
United States
Retinal Consultants Medical Group
Sacramento, California, 95841
United States
California Retina Consultants
Santa Barbara, California, 93103
United States
Macula Retina Vitreous Center
Torrance, California, 90503
United States
Retina Specialists of Colorado
Denver, Colorado, 80210
United States
Eye Care Center of Northern Colorado
Longmont, Colorado, 80503
United States
Sibia Eye Institute
Boynton Beach, Florida, 11195
United States
Blue Ocean Clinical Research
Clearwater, Florida, 33761
United States
Advanced Research
Coral Springs, Florida, 33067
United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308
United States
East Coast Institute for Research
Jacksonville, Florida, 32256
United States
Retina Consultants of Southwest Florida
Naples, Florida, 33912
United States
Marietta Eye Clinic
Marietta, Georgia, 30060
United States
Georgia Retina
Peachtree City, Georgia, 30269
United States
Illinois Retina Associates
Oak Park, Illinois, 60304
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
United States
Mississippi Retina Associates
Jackson, Mississippi, 90033
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
VitreoRetinal Consultants of NY
Hauppauge, New York, 11788
United States
Island Retina
Shirley, New York, 11967
United States
Vitreoretinal Consultants of NY
Westbury, New York, 11590
United States
Erie Retina Research
Erie, Pennsylvania, 16507
United States
Vision Research Solutions in Philadelphia
Philadelphia, Pennsylvania, 19141
United States
Palmetto Retina Center
West Columbia, South Carolina, 29169
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Tennessee Retina
Nashville, Tennessee, 37203
United States
Retina Consultants of Texas
Bellaire, Texas, 77401
United States
Star Retina
Burleson, Texas, 76028
United States
Houston Eye Associates, North Loop
Houston, Texas, 77025
United States
Austin Retina Associates
Round Rock, Texas, 78681
United States
San Antonio Eye Center - Downtown Clinic
San Antonio, Texas, 78215
United States
Retina Consultants of Texas
San Antonio, Texas, 78240-1657
United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
United States
Tyler Retina Consultants
Tyler, Texas, 75703
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States

Collaborators and Investigators

Sponsor: Oculis

  • Diana Do, MD, PRINCIPAL_INVESTIGATOR, Stanford Byers Eye Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-15
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-03-15
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Topical ophthalmic suspension
  • Eye drop

Additional Relevant MeSH Terms

  • Diabetic Macular Edema