Anti-VEGF Therapy for Acute Thyroid Eye Disease

Last updated: March 16, 2023
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Active - Recruiting

Phase

2

Condition

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT04311606
2019P000939
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Minimum of 18 years-old
  2. Active Thyroid Eye Disease
  3. Clinical Activity Score (CAS) between 3 and 5, inclusive
  4. Phakic and pseudophakic eyes are allowed in the study.
  5. Willing and able to provide written informed consent after the nature of the study hasbeen explained, and prior to any research-related procedures
  6. Willing and able to comply with clinic visits and study-related procedures
  7. 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, worseproptosis, worse eyelid retraction) will be enrolled. If both eyes are equivalent, we willenroll the non-dominant eye.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 24
Study Start date:
November 02, 2020
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Mass Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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