Bimatoprost as a Treatment for Graves' Orbitopathy | NCT03708627

Studies
Bimatoprost as a Treatment for Graves' Orbitopathy

NCT03708627

Sponsor

Johns Hopkins University

Status

Recruiting

Last Update Posted

Jul 17, 2025Actual

Enrollment

3Estimated

Phase

Early Phase 1

Conditions

Graves Ophthalmopathy

Interventions

Bimatoprost Ophthalmic

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Jul 1, 2029Estimated

Completion Date

Jul 1, 2031Estimated

First Submitted Date

Oct 13, 2018

First Submission Date that Met QC Criteria

Oct 13, 2018

First Posted Date

Oct 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2025

Last Update Posted Date

Jul 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bimatoprost in more proptotic eye	Experimental	Patients instill Bimatoprost in their more proptotic eye one nightly	Drug: Bimatoprost Ophthalmic
Control	No Intervention	Bimatoprost is not instilled in the patient's fellow eye

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bimatoprost Ophthalmic	Drug	Bimatoprost, aka Lumigan, one drop in one eye nightly	Bimatoprost in more proptotic eye

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emily Li, MD	Contact	410-955-1112		eli20@jhmi.edu

Overall Officials

Name	Affiliation	Role
Emily Li, MD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington	Recruiting	Seattle	Washington	98104	United States

Condition Browse Module

MeSH Terms

ID	Term
D049970	Graves Ophthalmopathy

Ancestor Terms

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D006111	Graves Disease
D005094	Exophthalmos

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

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

Who Masked

Outcomes Assessor