Anti-VEGF Therapy for Acute Thyroid Eye Disease
- Conditions
- Thyroid Eye Disease
- Interventions
- Drug: Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept
- Registration Number
- NCT04311606
- Lead Sponsor
- Massachusetts Eye and Ear Infirmary
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyaluronidase and aflibercept Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept Group 2: Sub-tenon's injection of hyaluronidase (HA) followed by sub-tenon injection of aflibercept Hyaluronidase alone Sub-tenon injection of hyaluronidase (HA) alone Group 3: Sub-tenon injection of HA injection alone Saline and aflibercept Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept Group 1: Sub-tenon's injection of saline followed by sub-tenon injection of aflibercept
- Primary Outcome Measures
Name Time Method Primary Outcome: Safety 45 days 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
- Secondary Outcome Measures
Name Time Method Secondary Outcome: Change in Ocular Alignment 1-90 days Change in degree of ocular misalignment during physical exam
Secondary Outcome: Change in Vision measured by Ishihara color test 1-90 days Change in vision as measured by Ishihara color test
Secondary Outcome: Change in Proptosis by CT scan 1-90 days Change in proptosis as measured by CT scan
Secondary Outcome: Change in Ocular Motility 1-90 days Change in limitation in ocular motility as measured with physical examination
Secondary Outcome: Change in Eyelid Retraction/Position 1-90 days Change in eyelid retraction/position as measured by the mm of inferior and superior scleral show on physical examination
Secondary Outcome: Safety Baseline to day 90 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
Secondary Outcome: Change in Proptosis measured by exophthalmometry 1-90 days Change in proptosis as measured by Hertel exophthalmometry
Secondary Outcome: Change in Vision measured by ETDRS BCVA 1-90 days Change in vision as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Secondary Outcome: Change in Visual Function 1-90 days Change in visual function as determined by automated Humphrey visual field
Secondary Outcome: Change in Clinical Activity 1-90 days Change in clinical activity as measured by a 2 point decrease on the clinical activity score (CAS)
Secondary Outcome: Change in Ocular Muscle 1-90 days Change in extra ocular muscle diameter as measured by computed tomography (CT) scan
Secondary Outcome: Change in Pain/Discomfort Reported by Subjects 1-90 days Change in subjective score of pain/discomfort based upon patient Graves' Ophthalmopathy Quality of Life (GO-QOL) questionnaire
Trial Locations
- Locations (1)
Mass Eye and Ear
🇺🇸Boston, Massachusetts, United States