Bimatoprost for Graves' Eye Disease

Overseen By Erin Godbout, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Johns Hopkins University

Must not be taking: Steroids

Disqualifiers: Active Graves disease, Pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether bimatoprost, an eye drop typically used for glaucoma, can reduce bulging eyes in individuals with Graves' disease. The study will determine if applying the drop to one eye can shrink the surrounding fatty tissues. Participants should have Graves' disease with noticeable eye bulging but should not be experiencing active symptoms or using steroids. As an Early Phase 1 trial, this research aims to understand bimatoprost's effects in people with Graves' disease, providing participants an opportunity to contribute to groundbreaking medical insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking steroids.

Is there any evidence suggesting that Bimatoprost Ophthalmic is likely to be safe for humans?

Research has shown that Bimatoprost, commonly used as an eye drop for glaucoma, is usually well tolerated. Some studies found that a few people might experience mild side effects like eye redness. However, strong evidence is lacking that Bimatoprost can reduce eye bulging or fat around the eyes in people with Graves' disease. As this study is in an early stage, safety information remains limited. However, the FDA has approved the treatment for other uses, indicating that its safety is well understood. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Graves' Eye Disease, which often involve corticosteroids or surgery, Bimatoprost offers a unique approach by targeting the eye's prostaglandin receptors to reduce intraocular pressure. This new mechanism of action could potentially alleviate the bulging eyes associated with the disease more effectively. Researchers are excited about Bimatoprost because its nightly eye drop administration is less invasive and could offer a more convenient option for patients.

What evidence suggests that Bimatoprost might be an effective treatment for Graves' disease?

Research has shown that Bimatoprost, initially used for glaucoma treatment, might aid in Graves' eye disease by reducing fat around the eyes. Some studies have found it can significantly decrease fat in this area, potentially alleviating the bulging eyes associated with Graves' disease. However, other research found that Bimatoprost did not reduce eye bulging or fat in some patients with inactive thyroid-related eye issues. The results are mixed, so while Bimatoprost shows potential, its effectiveness for this specific use remains unclear. In this trial, participants will apply Bimatoprost to their more proptotic eye to evaluate its effects. ^{1 2 4 5 6}

Who Is on the Research Team?

Emily Li, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have bulging eyes due to thyroid eye disease.

Exclusion Criteria

I have active Graves' disease.

I am currently taking steroids.

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants instill Bimatoprost in their more proptotic eye nightly

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimatoprost Ophthalmic

Trial Overview 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.

How Is the Trial Designed?

Group I: Bimatoprost in more proptotic eye Experimental Treatment 1 Intervention

Patients instill Bimatoprost in their more proptotic eye one nightly

Group II: Control Active Control 1 Intervention

Bimatoprost is not instilled in the patient's fellow eye

Bimatoprost Ophthalmic is already approved in United States, European Union for the following indications:

Approved in United States as Lumigan for:

• Open-angle glaucoma
• Ocular hypertension
• Eyelash hypotrichosis

Approved in European Union as Lumigan for:

• Open-angle glaucoma
• Ocular hypertension

Approved in United States as Latisse for:

• Eyelash hypotrichosis

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

In a study of 6,767 patients with glaucoma or ocular hypertension, bimatoprost 0.03% monotherapy significantly lowered intraocular pressure (IOP) by an average of 7.5 mmHg (30%) after 2 months, demonstrating its efficacy in untreated patients.

Bimatoprost was well tolerated, with 41.5% of patients achieving target IOPs of ≤15 mmHg and 75.8% reaching ≤18 mmHg, although the most common side effect reported was conjunctival hyperemia (7.9%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial. Quinones, R., Severin, T., Mundorf, T.[2015]

Chronic use of bimatoprost 0.03% for treating glaucoma can lead to significant periorbital changes, including fat atrophy and deepening of eyelid sulcus, observed in a study of 5 patients over up to 4 years.

These changes were confirmed to be reversible after stopping the medication, highlighting the importance of monitoring for these effects in patients using bimatoprost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periorbital changes associated with topical bimatoprost. Filippopoulos, T., Paula, JS., Torun, N., et al.[2022]

The bimatoprost implant (Durysta™) is a biodegradable drug delivery system that provides sustained release of bimatoprost to lower intraocular pressure (IOP) for 4 to 6 months, making it a convenient treatment option for patients with open angle glaucoma or ocular hypertension.

Approved in March 2020, the implant represents a significant advancement in glaucoma treatment, allowing for prolonged IOP control without the need for daily eye drops, and its clinical development is still ongoing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost Implant: First Approval. Shirley, M.[2020]

Bimatoprost 0.03% ophthalmic solution effectively reduces intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, showing better long-term results than timolol over a treatment period of up to 48 months.

The treatment is well tolerated, with common side effects including mild conjunctival hyperemia and eyelash growth, while also demonstrating similar or superior efficacy compared to other prostaglandin analogues like latanoprost and travoprost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension. Curran, MP.[2021]

Bimatoprost 0.03%, used for treating hypotrichosis and glaucoma, can cause significant periocular fat atrophy, leading to hollowing around the eyes in some patients, as observed in a retrospective review of 7 cases.

Both cosmetic (Latisse) and ophthalmic (Lumigan) formulations of bimatoprost are identical, so patients should be warned about the risk of irreversible fat changes, highlighting the need for careful consideration before prescribing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical bimatoprost 0.03% and iatrogenic eyelid and orbital lipodystrophy. Sira, M., Verity, DH., Malhotra, R.[2016]

Bimatoprost is a highly effective medication for lowering intraocular pressure in patients with glaucoma and ocular hypertension, providing consistent control throughout the day.

As a synthetic molecule similar to prostamide F(2), bimatoprost mimics prostamide activity, which contributes to its strong ocular hypotensive effects and indicates its unique pharmacological properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of bimatoprost. Cantor, LB.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6267500/

Treatment with bimatoprost for exophthalmos in patients ... Topical bimatoprost treatment did not reduce exophthalmos or orbital fat in this cohort of patients with inactive TAO.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6296211/

The Effect of Prostaglandin Analogue Bimatoprost on ... We characterize the effect of bimatoprost on orbital adipose tissue in thyroid-associated orbitopathy (TAO) with clinicopathologic correlation.

3. academic.oup.com academic.oup.com/jcem/article/107/Supplement_1/S47/6658345

Future Projections in Thyroid Eye Disease - Oxford Academic A recent meta-analysis reviewed 152 TED uncontrolled patients and indicated that patients treated with RTX had a significant reduction of the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02059655?term=AREA%5BInterventionSearch%5D(DINOPROST)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=5

Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease ... The objective of this study is to determine whether Bimatoprost eye drops are effective in reducing proptosis and thus improving quality of life ...

5. withpower.com withpower.com/trial/early-phase-1-eye-diseases-10-2017-39537?condition=Graves%27+Eye+Disease&overallStatus=Recruiting&hasNoPlacebo=false

Bimatoprost for Graves' Eye Disease Bimatoprost 0.03%, used for treating hypotrichosis and glaucoma, can cause significant periocular fat atrophy, leading to hollowing around the eyes in some ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03708627

Bimatoprost as a Treatment for Graves' Orbitopathy A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...