Could an eye injection ease thyroid eye disease? small trial tests safety
NCT ID NCT04311606
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 2 trial tested whether injections of aflibercept, a drug that blocks abnormal blood vessel growth, are safe for people with active thyroid eye disease. Eleven adults received three injections over a month, with or without hyaluronidase to help spread the drug. The main goal was to check for side effects, not to measure how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aflibercept (a drug that blocks blood vessel growth), given with either saline or hyaluronidase
- What this could lead to
- If it works, this could point toward a new treatment option for thyroid eye disease that reduces inflammation and eye bulging.
- What could go wrong
- This is a very early, small Phase 2 trial with only 11 people, focused mainly on safety. It may not show clear benefit, and aflibercept injections near the eye carry risks like infection or vision changes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
11 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mass Eye and Ear
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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