Celecoxib for Thyroid Eye Disease

Thyroid Eye Disease Clinical Trial

Official title:

An Open Label Trial of Celecoxib in the Treatment of Mild Thyroid Eye Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02845336
• Other study ID #: IRB00094787
• Status: Terminated
• Phase: Phase 2
• Start date: March 5, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks orbital tissues, resulting in characteristic changes in eyelid position, globe position in the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially blinding disease, and current treatments largely consist of nonspecific reduction of inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital changes become fixed and can be modified only by surgery.

The investigators propose to treat a cohort of patients with active TED using a selective COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group. The investigators hypothesize that celecoxib will reduce the severity of disease and/or prevent progression to proptosis, diplopia, and corneal exposure or compressive optic neuropathy.

Description:

The investigators intend to use celecoxib, a non-steroidal anti-inflammatory drug approved by the Food and Drug Administration (FDA) for the treatment of pain, osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as a treatment for active TED. In vitro data have shown that transformation of orbital fibroblasts into adipocytes is mediated by cyclooxygenase-2 (COX-2), and a case report suggests that COX-2 inhibition can improve TED in the acute phase. Thus, the investigators intend to evaluate the efficacy of COX-2 inhibition in the treatment of active TED and its ability to improve both the acute inflammatory signs and more permanent fibrotic changes of quiescent disease. The investigators will enroll patients with active TED and treat them for 3 months (a characteristic period of disease activity) and compare this to standard treatments for mild active TED (observation, with over the counter interventions such as lubrication with artificial tears) to assess efficacy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recent diagnosis of thyroid eye disease (within the past 3 months)

• Have ocular symptoms or signs of TED with a clinical activity score (CAS) of at least 3

Exclusion Criteria:

• Pregnancy

• Previous treatment with corticosteroid for TED for >2wks

• Previous treatment with orbital radiation for TED

• Impaired renal function

• Impaired hepatic function

• Treatment with antihypertensive medications except beta-blockers

• History of congestive heart failure, cardiac valvular disease, or coronary artery disease

• Allergy to NSAID or previous adverse reaction (ie. GI bleeding)

• Vision loss due to compressive optic neuropathy

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• Celecoxib
celecoxib 100mg PO twice per day for 3 months
• artificial tears
Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.

Locations

Country	Name	City	State
United States	Wilmer Eye Institute, Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyroid Eye Disease Clinical Activity Score	A clinical score based on examination findings at each clinic visit. Clinical Activity Scores ranged from 0 to 10; 0 = Normal 1-3 = Mild 4-6 = Moderate 7-10 = Severe	At baseline, 1, 3 and 6 months
Secondary	Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye)	A clinical measure of how prominent the eyes are and any change in this measure over the duration of the study, as measured in millimeters with an exophthalmometer.	At baseline, 1, 3 and 6 months
Secondary	Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye)	A clinical measure of how prominent the eyes are and any change in this measure over the duration of the study, as measured in millimeters with an exophthalmometer.	At baseline, 1, 3 and 6 months
Secondary	Number of Participants With Ocular Misalignment	Presence or absence of ocular misalignment measured in prism diopters.	At baseline
Secondary	Number of Participants With Ocular Misalignment	Presence or absence of ocular misalignment measured in prism diopters.	At 1 month
Secondary	Number of Participants With Ocular Misalignment	Presence or absence of ocular misalignment measured in prism diopters.	At 3 months
Secondary	Number of Participants With Ocular Misalignment	Presence or absence of ocular misalignment measured in prism diopters.	At 6 months
Secondary	Eyelid Retraction as Measured in Millimeters (Right Eye)	A clinical measure of the most common manifestation of thyroid eye disease--change in eyelid retraction as measured in millimeters at each visit over the duration of the study.	At baseline, 1, 3 and 6 months
Secondary	Eyelid Retraction as Measured in Millimeters (Left Eye)	A clinical measure of the most common manifestation of thyroid eye disease--change in eyelid retraction as measured in millimeters at each visit over the duration of the study.	At baseline, 1, 3 and 6 months
Secondary	Quality of Life as Assessed by a Thyroid Eye Disease Specific Survey of Quality of Life	Thyroid eye disease specific survey of quality of life will be administered, and change in quality of life score over the duration of the study will be measured.	6 months