Phase
Condition
Dry Eye Disease
Treatment
Intervention/Treatment
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Be able to understand the study procedures and the risks involved and be willing toprovide written informed consent before the first study-related activity
Have completed at least 5 IV infusions and assessments required to determineproptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) asdefined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found tobe a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study
Not require immediate surgical ophthalmological or orbital surgery in the study eyefor any reason
Must agree to use highly effective contraception as specified in the protocol
⦁ Female TED participants must have a negative urine pregnancy test at screening
- Be willing and able to comply with all the requirements of the protocol for theentire duration of the study
Exclusion
Key Exclusion Criteria:
Participants must not:
Have received prior treatment with another anti-IGF-1R agent
Have received systemic corticosteroids for any condition, including TED, or seleniumwithin 2 weeks prior to first dose
Have received other immunosuppressive drugs or another investigational agent for anycondition, including TED (other than VRDN-001 or placebo associated with theVRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose
Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
Have had previous orbital irradiation or decompression surgery involving excision offat for TED to the study eye's orbit
Must not have abnormal hearing test before first dose. Must also not have a historyof ear conditions considered significant by study doctor
Study Design
Connect with a study center
Centre Hospitalier Universitaire de Montperllier Hopital Lapeyronie
Montpellier Cedex 5, Hérault 34295
FranceSite Not Available
Centre Hospitalier Universitaire De Nantes G.R. Laenne
Saint-Herblain, Loire-Atlantique 44800
FranceSite Not Available
CHU Angers
Angers Cedex, 49933
FranceSite Not Available
Universitatmedizin Gottingen
Göttingen, Niedersachsen 37075
GermanySite Not Available
Charite - Universitatsmedizin Berlin KoR, Campus Virchow Klinikum, Klinik tor Augenheilkunde
Berlin,
GermanySite Not Available
Universitatsklinikum Carl Gustav Carus
Dresden,
GermanySite Not Available
Universitatsklinikum Essen AoR - Klinik fur Augenheilkunde
Essen,
GermanySite Not Available
University Medical Center Freiburg
Freiburg,
GermanySite Not Available
Amsterdam UMC
Amsterdam,
NetherlandsSite Not Available
Centrum Medyczne Piasta
Walbrzych, Piasta 58-304
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
PolandSite Not Available
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80809
PolandSite Not Available
Centrum Medyczne Pulawska
Piaseczno, 05-500
PolandSite Not Available
Hospital Arruzafa. Servicio de Oftalmologia
Córdoba, 14012
SpainSite Not Available
Hospital Clinico San Carlos
Madrid,
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario Virgen de la Macarena
Sevilla, 41009
SpainSite Not Available
Hospital Universitario Miguel Servel
Zaragoza, 50009
SpainSite Not Available
Gazi University Medical Faculty Hospital
Ankara, 06560
TurkeySite Not Available
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230
TurkeySite Not Available
Akdeniz University Medical Faculty Hospital
Antalya, 7070
TurkeySite Not Available
Marmara University Faculty of Medicine
Istanbul, 34899
TurkeySite Not Available
Norfolk and Norwich University ospital NHS Foundation Trust
Norwich, London
United KingdomSite Not Available
University Hospital Bristol and Weston NHS Foundation Trust- Bristol Eye Hospital
Bristol,
United KingdomSite Not Available
Guy's and St. Thomas Trust
London, SE17EH
United KingdomSite Not Available
Imperial College Healthcare NHS Trust Western Eye Hospital
London, NW15QH
United KingdomSite Not Available
Newcastle Eye Centre
Newcastle,
United KingdomSite Not Available
Advancing Research International, LLC
Los Angeles, California 90023
United StatesSite Not Available
MACRO Trials, Inc.
Los Angeles, California 90048
United StatesActive - Recruiting
Roski Eye Institute
Los Angeles, California 90033
United StatesActive - Recruiting
USC Eye Institute
Los Angeles, California 90033
United StatesSite Not Available
Advancing Research International, LLC
Newport Beach, California 90023
United StatesSite Not Available
Amy Patel Jain, MD Inc
Newport Beach, California 92660
United StatesActive - Recruiting
Byers Eye Institute
Palo Alto, California 94303
United StatesActive - Recruiting
Stanford Byers Eye Institute
Palo Alto, California 94303
United StatesSite Not Available
Cockerham Eye Consultants, PC
San Diego, California 92108
United StatesSite Not Available
University of Miami Miller School of Medicine, Bascom Palmer Eye Institute
Miami, Florida 33136
United StatesSite Not Available
Sarasota Retina Institute
Sarasota, Florida 34239
United StatesSite Not Available
Vision Medical Research
Oak Lawn, Illinois 60453
United StatesSite Not Available
Ophthalmic Consultants of Boston
E. Weymouth, Massachusetts 02189
United StatesSite Not Available
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts 02189
United StatesSite Not Available
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan 48152
United StatesSite Not Available
Ophthalmic Plastic, Reconstructive, Orbital and Cosmetic Surgery
Las Vegas, Nevada 89144
United StatesSite Not Available
Rutgers New Jersey Medical School
Newark, New Jersey 07103
United StatesSite Not Available
The Center for Eye and Facial Plastic Surgery
Somerset, New Jersey 08873
United StatesSite Not Available
Hospital of the University of Pennsylvania Perleman Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Alkek Eye Center
Houston, Texas 77030
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Neuro-Eye Clinical Trials
Houston, Texas 77074
United StatesSite Not Available
University of Vermont Medical Center
Burlington, Vermont 05401
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98104-2430
United StatesSite Not Available
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