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?

Testing whether Bimatoprost, a topical eye drop used for glaucoma, can be used to induce periorbital fat atrophy in patients with Graves' disease

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 bimatoprost generally safe for human use?

Bimatoprost, used in treatments like Lumigan and Latisse, is generally well tolerated, but some people may experience side effects like mild eye redness, eyelash growth, and itching. There is also a small risk of changes in fat around the eyes, which can be permanent, so it's important to discuss these potential side effects with your doctor. ^{1 2 3 4 5}

How is the drug bimatoprost unique for treating Graves' Eye Disease?

Bimatoprost is unique because it is a synthetic prostamide that lowers eye pressure by increasing fluid outflow, and it is typically used for glaucoma and ocular hypertension. Its use in Graves' Eye Disease is novel, as it may offer a new approach by leveraging its pressure-lowering effects, which are not standard for this condition. ^{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]

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%, 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 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 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]

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]

Citations

1. United States 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. [2015]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Bimatoprost Implant: First Approval. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Topical bimatoprost 0.03% and iatrogenic eyelid and orbital lipodystrophy. [2016]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of bimatoprost. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Periorbital changes associated with topical bimatoprost. [2022]