Could an eye injection ease thyroid eye disease? small trial tests safety

NCT ID NCT04311606

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

Nov 2020

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mass Eye and Ear

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.