Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2027
  • participants needed
    24
  • sponsor
    Massachusetts Eye and Ear Infirmary
Updated on 15 March 2022

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:

  1. Group 1: Sub-tenon's injection of saline followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye
  2. Group 2: Sub-tenon's injection of HA followed by injection of 4mg aflibercept (total volume 1.1 ml) in the worse eye
  3. 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 IdentifierNCT04311606
SponsorMassachusetts Eye and Ear Infirmary
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Minimum of 18 years-old
Active Thyroid Eye Disease
Clinical Activity Score (CAS) 3 and 5
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

Exclusion Criteria

History of orbital, strabismus, or eyelid surgery or orbital radiation
Optic neuropathy or other vision-threatening signs
Patients currently on systemic or topical steroids. If they received steroids in the
past, they would require a 6 week washout period and the cumulative dose of steroids
must be less than 1 gram of methylprednisolone (or equivalent). During the washout
period we will contact patients by phone weekly to monitor their safety and address
any concerns they may have related to no longer taking steroids
Patients who have taken teprotumumab (Tepezza.)
Patients who have received intraocular anti-VEGF medications within 1 year of
screening
Patients who have a history of receiving systemic anti-VEGF
Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion)
that could affect the VEGF levels within the eye
History of stroke or prior myocardial infarction
Known hypersensitivity to aflibercept
Infectious conjunctivitis, keratitis, or endophthalmitis of either eye
Presence of a glaucoma shunting or filtration device that is subconjunctival
Previous participation in any studies of investigational drugs within 1 month
preceding Day 0
Any clinically significant acute or chronic medical condition that would preclude
participation in a clinical study
Pregnant or breast-feeding women
Sexually active men _or women of childbearing potential_ who are unwilling to
practice adequate contraception during the study (adequate contraceptive measures
include stable use of oral contraceptives or other prescription pharmaceutical
contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device
[IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or
jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
History of hyaluronidase (HA) injection after the diagnosis of thyroid eye disease
Taking part in other research studies in the past 12 months that have involved
radiation exposure
Participated in other research studies in the past 12 months that required radiologic
imaging (particularly CT scans and not MRIs)
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