Anti-VEGF Therapy for Acute Thyroid Eye Disease

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Mar 16, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment for people with acute Thyroid Eye Disease, a condition that can cause swelling and discomfort around the eyes. Researchers want to see if a medication called aflibercept, given in combination with either saline (a saltwater solution) or hyaluronidase (an enzyme), is safe and well-tolerated. Participants will receive three injections over the course of the study, and the focus will be on monitoring any side effects or issues that arise from the treatment during the first 45 days.

To participate, you need to be at least 18 years old and have active Thyroid Eye Disease with specific symptoms. Only one eye will be treated, typically the one that is more affected. It’s important to note that individuals with a history of certain eye surgeries or those currently taking steroids may not be eligible. If you join the study, you can expect regular check-ups and support throughout the process. This trial is currently looking for participants, and your involvement could help contribute to better treatments for this condition.

Gender

ALL

Eligibility criteria

• 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 has been 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, worse proptosis, worse eyelid retraction) will be enrolled. If both eyes are equivalent, we will enroll the non-dominant eye.
• 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 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 .
• • 4. Patients who have taken teprotumumab (Tepezza.)
• • 5. Patients who have received intraocular anti-VEGF medications within 1 year of screening
• • 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 month preceding Day 0
• • 13. Any clinically significant acute or chronic medical condition that would preclude participation in a clinical study
• • 14. Pregnant or breast-feeding women
• • 15. 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)
• • 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 involved radiation exposure
• • 18. Participated in other research studies in the past 12 months that required radiologic imaging (particularly CT scans and not MRIs)