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Bimatoprost as a Treatment for Graves' Orbitopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03708627
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 18, 2018
Information provided by (Responsible Party):
Nora Silverman, University of Washington

Brief Summary:
Testing whether Bimatoprost, a topical eye drop used for glaucoma, can be used to induce periorbital fat atrophy in patients with Graves' disease

Condition or disease Intervention/treatment Phase
Graves Ophthalmopathy Drug: Bimatoprost Ophthalmic Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor will evaluate clinical photos. Other measures such as Hertel's exophthalmometry values are objective outcomes which will be made available to the Principal Investigator
Primary Purpose: Treatment
Official Title: The Role of Bimatoprost in Graves' Periorbitopathy
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Bimatoprost in more proptotic eye
Patients instill Bimatoprost in their more proptotic eye one nightly
Drug: Bimatoprost Ophthalmic
Bimatoprost, aka Lumigan, one drop in one eye nightly

No Intervention: Control
Bimatoprost is not instilled in the patient's fellow eye

Primary Outcome Measures :
  1. Reduction in periorbital fat causing improvement in proptosis [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -

Exclusion Criteria: Active Graves Disease, Currently pregnant, Taking Steroids


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03708627

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Contact: Nora Silverman, MD 206-543-7250
Contact: Christopher Chambers

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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Nora Siegal (previously Silverman), MD PhD    917-689-7219   
Sponsors and Collaborators
University of Washington
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Principal Investigator: Nora Silverman, MD University of Washington

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Responsible Party: Nora Silverman, Oculoplastics Fellow, University of Washington Identifier: NCT03708627     History of Changes
Other Study ID Numbers: STUDY00003194
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antihypertensive Agents