Bimatoprost as a Treatment for Graves' Orbitopathy

May 15, 2023 updated by: Johns Hopkins University

The Role of Bimatoprost in Graves' Periorbitopathy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington
        • Contact:
          • Alexandra Van Brummen, MD
          • Phone Number: 206-543-7250
          • Email: avanbrum@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in periorbital fat causing improvement in proptosis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Emily Li, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

October 13, 2018

First Submitted That Met QC Criteria

October 13, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00294393

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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