Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED Study)
The primary objective of this clinical trial is to assess the safety and tolerability of sub-tenon aflibercept in combination with either saline or hyaluronidase (HA) in patients with acute Thyroid Eye Disease (TED) as assessed by the incidence and severity of adverse events from baseline to day 45. Participants will undergo clinical examinations and receive three injections of aflibercept with saline, aflibercept with hyaluronidase, or hyaluronidase.
• Minimum of 18 years-old
• Active Thyroid Eye Disease
• Clinical Activity Score (CAS) between 3 and 5, inclusive
• Phakic and pseudophakic eyes are allowed in the study.
• Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures
• Willing and able to comply with clinic visits and study-related procedures
• Only one eye will be enrolled. The worse eye (demonstrating any of these features:
⁃ worse HVF results, worse restricted motility, worse visual acuity, worse edema, worse proptosis, worse eyelid retraction) will be enrolled. If both eyes are equivalent, we will enroll the non-dominant eye.