Bimatoprost as a Treatment for Graves' Orbitopathy

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03708627

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Graves Ophthalmopathy	Drug: Bimatoprost Ophthalmic	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel 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 :

Nov 1, 2017

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction in periorbital fat causing improvement in proptosis [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98104

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Emily Li, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT03708627

Other Study ID Numbers:

IRB00294393

First Posted:

Oct 17, 2018

Last Update Posted:

May 12, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Eye Diseases

Graves Ophthalmopathy

Bimatoprost

Study Results

No Results Posted as of May 12, 2022