Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED)
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- STATUS
- Recruiting
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- End date
- Jan 1, 2027
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- participants needed
- 24
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- sponsor
- Massachusetts Eye and Ear Infirmary
Summary
The primary objective 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.
Description
The study is a double-blinded exploratory investigation to evaluate use of sub-tenon injected HA or saline followed by sub-tenon injection of 4 mg aflibercept for the treatment of acute thyroid disease. The study will prospectively and sequentially enroll a total of twenty-four patients who meet the study enrollment criteria and will be randomized to one of three treatment arms:
- Group 1: Sub-tenon's injection of saline followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye
- Group 2: Sub-tenon's injection of HA followed by injection of 4mg aflibercept (total volume 1.1 ml) in the worse eye
- Group 3: HA injection alone (total volume 1.1 ml) in the worse eye
Study subjects will receive bi-weekly sub-tenon injections on day 1, day 14 and day 28 for a total of 3 treatments. Subjects will be followed for an additional 62 days (until the 90-day visit) after the last injection.
At the time of enrollment, patients will undergo a full ophthalmologic examination including external photography, a 30-2 automated Humphrey visual field, intraocular pressure, ocular motility and alignment, calculation of the CAS score, smoking status, measurement of blood pressure, a pre-treatment CT scan, and laboratory work-up (including plasma testing of TSI, thyroglobulin antibodies, thyroid peroxidase antibodies, cytokine levels (IL-6, IL-8, IFN-g, TNF-a, IL-1B, TGF-B) and a baseline measurement of systemic VEGF levels). The CAS is a 7-point clinical activity score and includes 1 point for the presence of each of the following: Redness of eyelids, spontaneous pain, pain when moving the globe, redness of conjunctiva, swelling of plica and/or caruncle, swelling of eyelid, and chemosis.
Careful clinical monitoring will follow initial injection including a complete re-evaluation on day 4 (CAS, motility exam, photos, patient questionnaire, measurement of blood pressure, and repeat thyroid antibody and cytokine levels). Patients will be re-evaluated in the same way on day 14, day 28, day 45, and day 60. A post-treatment CT scan will be obtained at day 45. A long-term follow-up visit will occur at day 90.
Details
| Condition | Thyroid Eye Disease |
|---|---|
| Treatment | Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept, Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept, Sub-tenon injection of hyaluronidase (HA) alone |
| Clinical Study Identifier | NCT04311606 |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Last Modified on | 15 March 2022 |
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