ACTIVE_NOT_RECRUITING

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

Talk to us

Conditions

Diabetic Macular EdemaTopical ophthalmic suspensionEye drop

Quick Navigation

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 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

Quick Facts

Study Start:2021-10-19
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05066997

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

Veeral S Sheth, MD
PRINCIPAL_INVESTIGATOR
University Retina - Lemont

Study Locations (Sites)

Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85016
United States
Phoenix Retina Associates
Phoenix, Arizona, 85050
United States
Retina Partners of Northwest Arkansas
Springdale, Arkansas, 72764
United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
United States
The Retina Partners
Encino, California, 91436
United States
Retinal Consultants Medical Group
Modesto, California, 95356
United States
California Eye Specialists Medical Group
Pasadena, California, 91107
United States
California Eye Specialists Medical Group
Redlands, California, 92373
United States
Retina Consultants of Southern California
Redlands, California, 92374
United States
California Retina Consultants
Santa Maria, California, 93454
United States
Beverly Hills Institute of Ophthalmology
Torrance, California, 90503
United States
Retina Group Of New England
Waterford, Connecticut, 06385
United States
Rand Eye Institute
Deerfield Beach, Florida, 33064
United States
Florida Retina Institute
Jacksonville, Florida, 32216
United States
MedEye Associates
Miami, Florida, 33143
United States
Florida Retina Institute
Orlando, Florida, 32806
United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410
United States
East Florida Eye Institute
Stuart, Florida, 34994
United States
Southeast Retina Center
Augusta, Georgia, 30909
United States
Retina Associates
Elmhurst, Illinois, 60126
United States
University Retina
Lemont, Illinois, 60439
United States
Midwest Eye Institute
Carmel, Indiana, 46290
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Retina Consultants of Minnesota
St. Louis Park, Minnesota, 55416
United States
The Retina Institute
Saint Louis, Missouri, 63128
United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, 13088
United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
United States
Velocity (Meridian) Clinical Research
Cincinnati, Ohio, 45202
United States
Verum Research LLC
Eugene, Oregon, 97401
United States
Vision Research Solutions in Philadelphia
Philadelphia, Pennsylvania, 19141
United States
Retina Consultants of Charleston
Beaufort, South Carolina, 29902
United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
United States
Retina Research Institute of Texas
Abilene, Texas, 79606
United States
Retina Consultants of Austin/Austin Research Center for Retina
Austin, Texas, 78705
United States
Retina Consultants of Texas
Beaumont, Texas, 77707
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
Retina Center of Texas
Grapevine, Texas, 76051
United States
Valley Retina Institute PA d.b.a. Gulf Coast Eye Institute
McAllen, Texas, 78503
United States
Retina Consultants of Texas
The Woodlands, Texas, 77384
United States
Tyler Retina Consultants
Tyler, Texas, 75703
United States
Strategic Clinical Research Group
Willow Park, Texas, 76087
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States

Collaborators and Investigators

Sponsor: Oculis

  • Veeral S Sheth, MD, PRINCIPAL_INVESTIGATOR, University Retina - Lemont

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 Date2021-10-19
Study Completion Date2026-04

Study Record Updates

Study Start Date2021-10-19
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