ACTIVE_NOT_RECRUITING

A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

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Conditions

Thyroid Eye Disease (TED)GravesThyroid Eye DiseaseThyroid-Associated OphthalmopathyDysthyroid OphthalmopathyGraves Eye DiseaseGraves OrbitopathyMyopathic OphthalmopathyCongestive 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 safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).

Official Title

A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Quick Facts

Study Start:2025-02-03
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06812325

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. * Have a clinical diagnosis of TED with or without proptosis and with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
  2. * Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
  3. * Must agree to use highly effective contraception as specified in the protocol
  4. * 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 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 8 weeks prior to first dose
  4. * Must not have received an investigational agent for any condition, including TED, within 8 weeks 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)

Catalina Eye Care
Tuscon, Arizona, 85712
United States
United Medical Research Institute
Inglewood, California, 90301
United States
Orbital Plastics
Newport Beach, California, 92660
United States
California Eye Specialists Medical Group INC
Pasadena, California, 91107
United States
Pacific Neuroscience Institute
Santa Monica, California, 90404
United States
Pacific Neuroscience Institute at Saint John's Physician Partners
Torrance, California, 90503
United States
C A Clinical Trial Corp.
Cape Coral, Florida, 33990
United States
Herco Medical and Research Center
Coral Gables, Florida, 33134
United States
Alfa Medical Research
Davie, Florida, 33024
United States
D H Doral Research Center
Doral, Florida, 33132
United States
Eye Centers of Florida
Fort Myers, Florida, 33901
United States
Sina Medical Center
Homestead, Florida, 33034
United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
United States
Southern Clinical Research LLC
Miami, Florida, 33125
United States
Retreat Medical Research
Miami, Florida, 33135
United States
Continental Clinical Research
Miami, Florida, 33144
United States
Edward Jenner Research Group LLC
Plantation, Florida, 33317
United States
Sarasota Retina Institute
Sarasota, Florida, 34239
United States
Advanced Quality Medical Research
Orland Park, Illinois, 60462
United States
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189
United States
Fraser Eye Care Center
Fraser, Michigan, 48026
United States
University of Missouri Kansas City
Kansas City, Missouri, 64108
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
United States
Jackson Clinic
Jackson, Tennessee, 38305
United States
DFW Clinical Trials
Carrollton, Texas, 75010
United States
Neuro Eye Clinical Trials
Houston, Texas, 77074
United States
Pioneer Research Solutions Inc.
Houston, Texas, 77099
United States
San Antonio Clinical Trials
San Antonio, Texas, 78240
United States
Eyeplastx
San Antonio, Texas, 78258
United States
Elevate Clinical Research
Seabrook, Texas, 77586
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 Date2025-02-03
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Thyroid Eye Disease (TED)