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Prostaglandin Analog

Bimatoprost for Graves' Eye Disease

Phase < 1
Recruiting
Led By Erin Godbout, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Graves' Ophthalmopathy with Exophthalmos/Proptosis
Be older than 18 years old
Must not have
Active Graves Disease
Taking Steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a drug used for glaucoma can also be used to reduce the fat around the eyes in patients with Graves' disease.

Who is the study for?
This trial is for individuals with Graves' Eye Disease who are experiencing bulging eyes (Exophthalmos/Proptosis). Participants should not have active Graves' disease, be pregnant, or be taking steroids.
What is being tested?
The study is examining if Bimatoprost eye drops, commonly used for glaucoma, can help reduce the swelling around the eyes in patients with Graves' Orbitopathy by causing fat loss in that area.
What are the potential side effects?
Bimatoprost may cause side effects such as redness of the eyes, itching or burning sensation, eye irritation, dry eyes and potential darkening of the eyelid skin or iris.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have bulging eyes due to thyroid eye disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have active Graves' disease.
Select...
I am currently taking steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bimatoprost in more proptotic eyeExperimental Treatment1 Intervention
Patients instill Bimatoprost in their more proptotic eye one nightly
Group II: ControlActive Control1 Intervention
Bimatoprost is not instilled in the patient's fellow eye
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimatoprost Ophthalmic
2023
Completed Phase 3
~730

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,783 Total Patients Enrolled
University of WashingtonLead Sponsor
1,829 Previous Clinical Trials
1,907,091 Total Patients Enrolled
Erin Godbout, MDPrincipal InvestigatorUniversity of Washington
Emily Li, MDPrincipal Investigator - Johns Hopkins University
The Mount Sinai Hospital
Medical School - New York Institute of Technology, New York College of Osteopathic Medicine, Doctor of Osteopathic Medicine
Nassau University Medical Center, Residency in Family Medicine

Media Library

Bimatoprost Ophthalmic (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT03708627 — Phase < 1
Graves' Eye Disease Research Study Groups: Bimatoprost in more proptotic eye, Control
Graves' Eye Disease Clinical Trial 2023: Bimatoprost Ophthalmic Highlights & Side Effects. Trial Name: NCT03708627 — Phase < 1
Bimatoprost Ophthalmic (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03708627 — Phase < 1
~1 spots leftby Jul 2028
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