ACTIVE_NOT_RECRUITING

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)

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Conditions

Thyroid Eye DiseaseTEDGravesThyroid-Associated OphthalmopathyDysthyroid OphthalmopathyGraves Eye DiseaseGraves OrbitopathyMyopathic OphthalmopathyEdematous OphthalmopathyInfiltrative Ophthalmopathy

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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

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic Thyroid Eye Disease (TED).

Official Title

REVEAL-2 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)

Quick Facts

Study Start:2024-08-27
Study Completion:2026-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06625398

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 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
  2. * Must agree to use highly effective contraception as specified in the protocol
  3. * Female TED participants must have a negative serum pregnancy test at screening
  1. * Must not have received prior treatment with another anti-IGF-1R therapy
  2. * Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose.
  3. * Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose
  4. * Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
  5. * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
  6. * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
  7. * Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
  8. * Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
  9. * Must not have a history of inflammatory bowel disease
  10. * Female TED participants must not be pregnant or breastfeeding

Contacts and Locations

Study Locations (Sites)

Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
United States
Alliance Research Institute - Canoga Park
Canoga Park, California, 91304
United States
Marvel Clinical Research
Huntington Beach, California, 92647
United States
United Medical Research Institute
Inglewood, California, 90301
United States
Advancing Research International, LLC
Los Angeles, California, 90023
United States
Roski Eye Institute, Keck School of Medicine, USC
Los Angeles, California, 90033
United States
Alliance Research Institute - Lynwood
Lynwood, California, 90262
United States
A.P.J. Office
Newport Beach, California, 92660
United States
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
United States
Pasadena Clinical Trials
Pasadena, California, 91101
United States
Senta Clinic
San Diego, California, 92108
United States
Ilumina Medical Research
Kissimmee, Florida, 34744
United States
Med-Care Research
Miami, Florida, 33125
United States
Hype Clinical Research LLC
Miami, Florida, 33145
United States
Anmed Health Services LLC
Miami, Florida, 33193
United States
Southern Clinical Research LLc
Miami, Florida, 33990
United States
Sarasota Retina Institute
Sarasota, Florida, 34239
United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
United States
Vision Medical Research
Orland Park, Illinois, 60462
United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States
Opthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189
United States
Fraser Eye Care Center
Fraser, Michigan, 48026
United States
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152
United States
University Health
Kansas City, Missouri, 64108
United States
S.L. Office
Las Vegas, Nevada, 89144
United States
Vector Clinical Trials
Sparks, Nevada, 89436
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
United States
Asheville Clinical Research
Asheville, North Carolina, 28803
United States
Duke Eye Center
Durham, North Carolina, 27710
United States
Scheie Eye Institute Penn Presbyterian
Philadelphia, Pennsylvania, 19104
United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
United States
Horizon Clinical Research Group
Cypress, Texas, 77429
United States
Baylor College of Medicine/Alkek Eye Center
Houston, Texas, 77030
United States
Gulf Coast Clinical Trials
Houston, Texas, 77070
United States
Neuro-Eye Clinical Trials
Houston, Texas, 77074
United States
University of Washington, Eye institute
Seattle, Washington, 98104
United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Viridian Therapeutics, Inc.

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 Date2024-08-27
Study Completion Date2026-12-15

Study Record Updates

Study Start Date2024-08-27
Study Completion Date2026-12-15

Terms related to this study

Keywords Provided by Researchers

  • TED
  • Thyroid Eye Disease
  • Graves
  • Thyroid-Associated Ophthalmopathy
  • Dysthyroid Ophthalmopathy
  • Graves Eye Disease
  • Graves Orbitopathy
  • Myopathic Ophthalmopathy
  • Edematous Ophthalmopathy
  • Infiltrative Ophthalmopathy

Additional Relevant MeSH Terms

  • Thyroid Eye Disease