An Open-label Study for Non-responders of VRDN-001-101 and VRDN-001-301 (OLE)

Last updated: March 27, 2025
Sponsor: Viridian Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dry Eye Disease

Treatment

Intervention/Treatment

Clinical Study ID

NCT06179875
VRDN-001-302
  • Ages > 18
  • All Genders

Study Summary

An open-label study for participants who received VRDN-001 or placebo and were non-responders at end of the treatment period assessment (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Be able to understand the study procedures and the risks involved and be willing toprovide written informed consent before the first study-related activity

  2. 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

  3. 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

  4. Not require immediate surgical ophthalmological or orbital surgery in the study eyefor any reason

  5. Must agree to use highly effective contraception as specified in the protocol

⦁ Female TED participants must have a negative urine pregnancy test at screening

  1. 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:

  1. Have received prior treatment with another anti-IGF-1R agent

  2. Have received systemic corticosteroids for any condition, including TED, or seleniumwithin 2 weeks prior to first dose

  3. 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

  4. Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose

  5. Have had previous orbital irradiation or decompression surgery involving excision offat for TED to the study eye's orbit

  6. Must not have abnormal hearing test before first dose. Must also not have a historyof ear conditions considered significant by study doctor

Study Design

Total Participants: 143
Treatment Group(s): 1
Primary Treatment: Intervention/Treatment
Phase: 3
Study Start date:
February 01, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Centre Hospitalier Universitaire de Montperllier Hopital Lapeyronie

    Montpellier Cedex 5, Hérault 34295
    France

    Site Not Available

  • Centre Hospitalier Universitaire De Nantes G.R. Laenne

    Saint-Herblain, Loire-Atlantique 44800
    France

    Site Not Available

  • CHU Angers

    Angers Cedex, 49933
    France

    Site Not Available

  • Universitatmedizin Gottingen

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Charite - Universitatsmedizin Berlin KoR, Campus Virchow Klinikum, Klinik tor Augenheilkunde

    Berlin,
    Germany

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus

    Dresden,
    Germany

    Site Not Available

  • Universitatsklinikum Essen AoR - Klinik fur Augenheilkunde

    Essen,
    Germany

    Site Not Available

  • University Medical Center Freiburg

    Freiburg,
    Germany

    Site Not Available

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Site Not Available

  • Centrum Medyczne Piasta

    Walbrzych, Piasta 58-304
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276
    Poland

    Site Not Available

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80809
    Poland

    Site Not Available

  • Centrum Medyczne Pulawska

    Piaseczno, 05-500
    Poland

    Site Not Available

  • Hospital Arruzafa. Servicio de Oftalmologia

    Córdoba, 14012
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servel

    Zaragoza, 50009
    Spain

    Site Not Available

  • Gazi University Medical Faculty Hospital

    Ankara, 06560
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230
    Turkey

    Site Not Available

  • Akdeniz University Medical Faculty Hospital

    Antalya, 7070
    Turkey

    Site Not Available

  • Marmara University Faculty of Medicine

    Istanbul, 34899
    Turkey

    Site Not Available

  • Norfolk and Norwich University ospital NHS Foundation Trust

    Norwich, London
    United Kingdom

    Site Not Available

  • University Hospital Bristol and Weston NHS Foundation Trust- Bristol Eye Hospital

    Bristol,
    United Kingdom

    Site Not Available

  • Guy's and St. Thomas Trust

    London, SE17EH
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust Western Eye Hospital

    London, NW15QH
    United Kingdom

    Site Not Available

  • Newcastle Eye Centre

    Newcastle,
    United Kingdom

    Site Not Available

  • Advancing Research International, LLC

    Los Angeles, California 90023
    United States

    Site Not Available

  • MACRO Trials, Inc.

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Roski Eye Institute

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • USC Eye Institute

    Los Angeles, California 90033
    United States

    Site Not Available

  • Advancing Research International, LLC

    Newport Beach, California 90023
    United States

    Site Not Available

  • Amy Patel Jain, MD Inc

    Newport Beach, California 92660
    United States

    Active - Recruiting

  • Byers Eye Institute

    Palo Alto, California 94303
    United States

    Active - Recruiting

  • Stanford Byers Eye Institute

    Palo Alto, California 94303
    United States

    Site Not Available

  • Cockerham Eye Consultants, PC

    San Diego, California 92108
    United States

    Site Not Available

  • University of Miami Miller School of Medicine, Bascom Palmer Eye Institute

    Miami, Florida 33136
    United States

    Site Not Available

  • Sarasota Retina Institute

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Vision Medical Research

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    E. Weymouth, Massachusetts 02189
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    East Weymouth, Massachusetts 02189
    United States

    Site Not Available

  • Kahana Oculoplastic & Orbital Surgery

    Livonia, Michigan 48152
    United States

    Site Not Available

  • Ophthalmic Plastic, Reconstructive, Orbital and Cosmetic Surgery

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Rutgers New Jersey Medical School

    Newark, New Jersey 07103
    United States

    Site Not Available

  • The Center for Eye and Facial Plastic Surgery

    Somerset, New Jersey 08873
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania Perleman Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Alkek Eye Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Neuro-Eye Clinical Trials

    Houston, Texas 77074
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98104-2430
    United States

    Site Not Available

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