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Anti-VEGF Therapy for Acute Thyroid Eye Disease
Sponsor: Massachusetts Eye and Ear Infirmary
Summary
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.
Official title: Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2020-11-02
Completion Date
2024-12-17
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept
The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of saline followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90.
Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept
The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of hyaluronidase (HA) followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90.
Sub-tenon injection of hyaluronidase (HA) alone
The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of hyaluronidase (HA) injection alone (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90.
Locations (1)
Mass Eye and Ear
Boston, Massachusetts, United States