Teprotumumab for treating thyroid eye disease and thyroid dysfunction
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Walter Reed National Military Medical Center · NCT06275373
This study is testing how well teprotumumab can help people with thyroid eye disease who have serious symptoms like bulging eyes, pain, and double vision.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Walter Reed National Military Medical Center (fed) |
| Drugs / interventions | radiation, teprotumumab |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06275373 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the clinical outcomes of patients with active thyroid eye disease who exhibit significant symptoms such as proptosis, pain, and diplopia. Patients recommended for treatment with teprotumumab infusion will be assessed by an oculoplastic surgeon and an endocrinologist. The study aims to monitor the effects of teprotumumab on the symptoms and progression of thyroid eye disease, which is a debilitating autoimmune condition affecting the eyes.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older with symptoms of thyroid eye disease associated with autoimmune thyroid disease.
Not a fit: Patients with compressive optic neuropathy requiring urgent intervention or those with uncontrolled diabetes or inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from thyroid eye disease by alleviating debilitating symptoms.
How similar studies have performed: Previous studies have shown promise with teprotumumab in treating thyroid eye disease, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Thanh D Hoang, DO — Walter Reed National Military Medical Center
- Study coordinator: THANH D HOANG, DO
- Email: thanh.d.hoang.mil@health.mil
- Phone: 3012955165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Eye Disease, Graves Ophthalmopathy, Graves Disease, Thyroid eye disease, Graves ophthalmopathy, Graves disease