Recruiting

Teprotumumab

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT06275373

Conditions

Thyroid Eye Disease

Graves Ophthalmopathy

Graves Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Teprotumumab Injection [Tepezza]

Study Details

Brief summary:

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).

Conditions

Thyroid Eye Disease

Graves Ophthalmopathy

Graves Disease

Study ID

NCT06275373

Start date

May 12, 2021

Status verified date

Feb, 2024

Completion date

Dec 12, 2027

Anticipated

Primary completion date

May 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Teprotumumab Injection [Tepezza]

IGF1 monoclonal antibody

Primary outcome measure

  • Ophthalmological Clinical Activity Score (CAS) scoring [ Time Frame: 6-12 months post treatment ]
  • Thyroid stimulating immunoglobulin [ Time Frame: 6-12 months post treatment ]

Central Contacts and Locations

Central contacts

THANH D HOANG, DO

3012955165thanh.d.hoang.mil@health.mil

Iris Morris, PhD

3013194599iris.e.morris3.civ@health.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Thanh D Hoang, DO

301-295-5165thanh.d.hoang.mil@health.mil

Iris E Morris, PhD

3013194599iris.e.morris3.civ@health.mil

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Keywords

  • Thyroid eye disease
  • Graves ophthalmopathy
  • Graves disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2024-02-23.