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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
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.
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.
Mass Eye and Ear
Boston, Massachusetts, United States
Primary Outcome: Safety
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
Time frame: 45 days
Secondary Outcome: Safety
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
Time frame: Baseline to day 90
Secondary Outcome: Change in Clinical Activity
Change in clinical activity as measured by a 2 point decrease on the clinical activity score (CAS)
Time frame: 1-90 days
Secondary Outcome: Change in Ocular Muscle
Change in extra ocular muscle diameter as measured by computed tomography (CT) scan
Time frame: 1-90 days
Secondary Outcome: Change in Proptosis measured by exophthalmometry
Change in proptosis as measured by Hertel exophthalmometry
Time frame: 1-90 days
Secondary Outcome: Change in Proptosis by CT scan
Change in proptosis as measured by CT scan
Time frame: 1-90 days
Secondary Outcome: Change in Ocular Alignment
Change in degree of ocular misalignment during physical exam
Time frame: 1-90 days
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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.
Secondary Outcome: Change in Ocular Motility
Change in limitation in ocular motility as measured with physical examination
Time frame: 1-90 days
Secondary Outcome: Change in Vision measured by ETDRS BCVA
Change in vision as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Time frame: 1-90 days
Secondary Outcome: Change in Vision measured by Ishihara color test
Change in vision as measured by Ishihara color test
Time frame: 1-90 days
Secondary Outcome: Change in Visual Function
Change in visual function as determined by automated Humphrey visual field
Time frame: 1-90 days
Secondary Outcome: Change in Pain/Discomfort Reported by Subjects
Change in subjective score of pain/discomfort based upon patient Graves' Ophthalmopathy Quality of Life (GO-QOL) questionnaire
Time frame: 1-90 days
Secondary Outcome: Change in Eyelid Retraction/Position
Change in eyelid retraction/position as measured by the mm of inferior and superior scleral show on physical examination
Time frame: 1-90 days