Health TrialsbyHealthPanel

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

ConditionsThyroid Eye DiseaseGraves OphthalmopathyGraves Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWalter Reed National Military Medical Center

About this trial

This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

only DOD beneficiaries

adult patients 18 years of age or older

adult patients with proptosis, ocular/orbital pain, diplopia, lid/orbital edema, or lid/orbital erythema associated with autoimmune thyroid disease

Disqualifiers

Patients with evidence of compressive optic neuropathy necessitating urgent orbital decompression or external beam radiation

patients with a history of uncontrolled diabetes mellitus

patients with a history/diagnosis of uncontrolled inflammatory bowel disease

patients under age 18 years

Trial population

The study participants were 18-80 years old at the time of treatment with teprotumumab, diagnosed with autoimmune thyroid disease (positive stimulating thyroid receptor antibodies or elevated TSI), presenting with active eye disease (associated with at least one of the following: lid retraction of ≥2 mm, moderate or severe soft-tissue involvement, proptosis of ≥3 mm above the normal values for race and sex, and periodic or constant diplopia), and treated with at least one dose of teprotumumab.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Teprotumumab Injection [Tepezza]

    Drug

    IGF1 monoclonal antibody

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Ophthalmological Clinical Activity Score (CAS) scoring

CAS scoring (1 to 10)

Time frame
6-12 months post treatment
2

Thyroid stimulating immunoglobulin

TSI (IU/L)

Time frame
6-12 months post treatment

Secondary outcomes

1

HLA subtypes

HLA subtypes

Time frame
6-12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Walter Reed National Military Medical Center

Lead sponsor

Source ClinicalTrials.gov
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