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Clinical trial

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

ID
Name
20-10974
Description
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).
Trial arms
Trial start
2021-05-12
Estimated PCD
2026-05-12
Trial end
2027-12-12
Status
Recruiting
Treatment
Teprotumumab Injection [Tepezza]
IGF1 monoclonal antibody
Other names:
Tepezza TM
Size
100
Primary endpoint
Ophthalmological Clinical Activity Score (CAS) scoring
6-12 months post treatment
Thyroid stimulating immunoglobulin
6-12 months post treatment
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * patients who are pregnant or trying to become pregnant.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-02-23

1 organization

1 product

3 indications

Organization
Walter Reed National Military Medical Center
Product
Teprotumumab
Indication
Graves' Disease
Indication
Graves Ophthalmopathy
Indication
Graves disease