A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
• Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
• Must agree to use highly effective contraception as specified in the protocol
• Female TED participants must have a negative serum pregnancy test at screening
Locations
United States
Arizona
Catalina Eye Care
RECRUITING
Tuscon
California
United Medical Research Institute
RECRUITING
Inglewood
Orbital Plastics
RECRUITING
Newport Beach
California Eye Specialists Medical Group INC
RECRUITING
Pasadena
Pacific Neuroscience Institute
RECRUITING
Santa Monica
Pacific Neuroscience Institute at Saint John's Physician Partners
RECRUITING
Torrance
Florida
C A Clinical Trial Corp.
RECRUITING
Cape Coral
Herco Medical and Research Center
RECRUITING
Coral Gables
Alfa Medical Research
RECRUITING
Davie
D H Doral Research Center
RECRUITING
Doral
Eye Centers of Florida
RECRUITING
Fort Myers
Sina Medical Center
RECRUITING
Homestead
East Coast Institute for Research, LLC
RECRUITING
Jacksonville
Continental Clinical Research
RECRUITING
Miami
Retreat Medical Research
RECRUITING
Miami
Southern Clinical Research LLC
RECRUITING
Miami
Edward Jenner Research Group LLC
RECRUITING
Plantation
Sarasota Retina Institute
RECRUITING
Sarasota
Illinois
Advanced Quality Medical Research
RECRUITING
Orland Park
Massachusetts
Ophthalmic Consultants of Boston
RECRUITING
East Weymouth
Michigan
Fraser Eye Care Center
RECRUITING
Fraser
Missouri
University of Missouri Kansas City
RECRUITING
Kansas City
New Jersey
Rutgers New Jersey Medical School
RECRUITING
Newark
Tennessee
Jackson Clinic
RECRUITING
Jackson
Texas
DFW Clinical Trials
RECRUITING
Carrollton
Neuro Eye Clinical Trials
RECRUITING
Houston
Pioneer Research Solutions Inc.
RECRUITING
Houston
Eyeplastx
RECRUITING
San Antonio
San Antonio Clinical Trials
RECRUITING
San Antonio
Elevate Clinical Research
RECRUITING
Seabrook
Other Locations
Germany
Universitaetsmedizin Goettingen
RECRUITING
Göttingen
Poland
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Okulistyki, Centrum Badań Klinicznych
RECRUITING
Bialystok
Optimum Profesorskie Centrum Okulistyki Sp. z o. o.
RECRUITING
Gdansk
Centrum Medyczne Pratia Gdynia
RECRUITING
Gdynia
Santa Familia PTG Lodz
RECRUITING
Lodz
ETG Lublin
RECRUITING
Lublin
Centrum Medyczne Pulawska Sp. z o.o.
RECRUITING
Piaseczno
Polimedica PTG
RECRUITING
Warsaw
Warszawski Szpital Okulistyczny
RECRUITING
Warsaw
Spain
Hospital Provincial de Conxo
RECRUITING
A Coruña
Institut Català de Retina
RECRUITING
Barcelona
Hospital La Arruzafa
RECRUITING
Córdoba
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Turkey
Akdeniz Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı
RECRUITING
Antalya
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Stephen Director, Clinical Operations
sgust@viridiantherapeutic.com
551-265-2151
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 284
Treatments
Experimental: VRDN-003 every 4 weeks
6 subcutaneous administrations of VRDN-003
Experimental: VRDN-003 every 8 weeks
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Related Therapeutic Areas
Sponsors
Leads: Viridian Therapeutics, Inc.