Anti-VEGF Therapy for Acute Thyroid Eye Disease

Phase

Condition

Dry Eye Disease

Treatment

Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept

Sub-tenon injection of hyaluronidase (HA) alone

Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept

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:

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 studyhas 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

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 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 .
Patients who have taken teprotumumab (Tepezza.)
Patients who have received intraocular anti-VEGF medications within 1 year ofscreening
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 monthpreceding Day 0
Any clinically significant acute or chronic medical condition that would precludeparticipation in a clinical study
Pregnant or breast-feeding women
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; intrauterinedevice [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 involvedradiation exposure
Participated in other research studies in the past 12 months that requiredradiologic imaging (particularly CT scans and not MRIs)

Study Design