Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID03708627

The Role of Bimatoprost in Graves' Periorbitopathy

Led by Johns Hopkins University · Updated on 2025-07-17

3

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Bimatoprost, a topical eye drop commonly used for glaucoma, to see if it can reduce periorbital fat and improve the appearance of bulging eyes in patients with Graves' Ophthalmopathy. This early phase 1 trial focuses on patients experiencing eye bulging (proptosis) caused by this condition. The study aims to understand if applying Bimatoprost can help improve this specific eye symptom. Participants will apply one drop of Bimatoprost eye drops nightly to their more proptotic (more bulging) eye, while the other eye will not receive any treatment. This allows comparison between the treated and untreated eye within the same patient. The study does not involve randomization and uses a single-blind design. The treatment period and observation for changes last one year. Throughout the study, researchers will monitor changes in periorbital fat and improvement in eye bulging over a 12-month period. Participants will likely attend regular visits for assessment and monitoring of treatment effects. The main measurement is the reduction in periorbital fat causing improvement in proptosis. Safety and any side effects will also be observed during the study duration, which is planned to continue until July 2031.

CONDITIONS

Brief Title

Bimatoprost as a Treatment for Graves' Orbitopathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Graves' Ophthalmopathy with exophthalmos/proptosis
  • Age 18 years or older
  • All genders are eligible
Not Eligible

You will not qualify if you...

  • Active Graves Disease
  • Currently pregnant
  • Taking steroid medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 year

Participants use Bimatoprost ophthalmic drops nightly in the more proptotic eye as part of the study treatment.

Regular visits to monitor treatment effects

Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

E

Emily Li, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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