Moderate-to-Severe Active Thyroid Eye Disease with Significant Proptosis or Diplopia When First-Line Therapy Has Not Met Target Outcomes
This protocol covers patients with active moderate-to-severe Graves’ orbitopathy who have significant proptosis and/or diplopia with sufficient impact on daily life to justify intervention, but who did not achieve the required response from first-line systemic therapy at 24 weeks.
Clinical Situation
Moderate-to-severe thyroid eye disease in the active phase, with significant proptosis of the eye and/or diplopia. The burden of disease is sufficient to justify the risks of intervention; this population does not have sight-threatening disease.
Why This Protocol Is Reached
First-line therapy attempted: teprotumumab, radiotherapy, intravenous glucocorticoids, or oral glucocorticoids.
Target outcomes not achieved at 24 weeks: reduction in proptosis of ≥2 mm and improvement in diplopia.
Non-achievement of both goals in the active phase leads to this next-step protocol, which is pursued once the disease has transitioned to the inactive phase.
Next-Step Approach
Clinical Goals
- Restoration of binocular single vision in the primary position of gaze
- Reduction of proptosis (approximately 2 mm for each orbital wall removed)
References
doi: 10.1089/thy.2022.0251
- Patients without sight-threatening disease whose eye disease has sufficient impact on daily life to justify the risks of medical or surgical intervention.
- TEP is a preferred therapy, if available, in patients with active moderate-to-severe TED with significant proptosis (see Section 2.1. for definition) and/or diplopia.
- The specific surgical approach should be tailored to the indication (DON, proptosis), type of orbitopathy (muscle or fat predominant congestive disease), and desired reduction in proptosis.
- In patients with diplopia and inactive TED, binocular single vision in the primary position of gaze may be restored with strabismus surgery or permanent prisms ground into the spectacle lenses.
- Approximately 2 mm of proptosis reduction may be expected for each wall removed or 2 cm³ of fat excision.