Back to resultsBimatoprost as a Treatment for Graves' Orbitopathy
Primary Purpose
Graves Ophthalmopathy
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost Ophthalmic
Sponsored by
About this trial
This is an interventional treatment trial for Graves Ophthalmopathy
Eligibility Criteria
Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -
Exclusion Criteria: Active Graves Disease, Currently pregnant, Taking Steroids
-
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bimatoprost in more proptotic eye
Control
Arm Description
Patients instill Bimatoprost in their more proptotic eye one nightly
Bimatoprost is not instilled in the patient's fellow eye
Outcomes
Primary Outcome Measures
Reduction in periorbital fat causing improvement in proptosis
Secondary Outcome Measures
Full Information
NCT ID
NCT03708627
First Posted
October 13, 2018
Last Updated
May 15, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03708627
Brief Title
Bimatoprost as a Treatment for Graves' Orbitopathy
Official Title
The Role of Bimatoprost in Graves' Periorbitopathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Ophthalmopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Non-Randomized
Enrollment
3 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost in more proptotic eye
Arm Type
Experimental
Arm Description
Patients instill Bimatoprost in their more proptotic eye one nightly
Arm Title
Control
Arm Type
No Intervention
Arm Description
Bimatoprost is not instilled in the patient's fellow eye
Intervention Type
Drug
Intervention Name(s)
Bimatoprost Ophthalmic
Intervention Description
Bimatoprost, aka Lumigan, one drop in one eye nightly
Primary Outcome Measure Information:
Title
Reduction in periorbital fat causing improvement in proptosis
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -
Exclusion Criteria: Active Graves Disease, Currently pregnant, Taking Steroids
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Li, MD
Phone
410-955-1112
Email
eli20@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Li, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Van Brummen, MD
Phone
206-543-7250
Email
avanbrum@uw.edu
12. IPD Sharing Statement
Learn more about this trial
Bimatoprost as a Treatment for Graves' Orbitopathy
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