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Anti-VEGF Therapy for Acute Thyroid Eye Disease | Clinical Trials | Clareo Health

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Anti-VEGF Therapy for Acute Thyroid Eye Disease

Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED Study)

NCT04311606•Massachusetts Eye and Ear Infirmary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (1)

Mass Eye and Ear

Boston, Massachusetts, United States

Key Dates

Start Date

November 2, 2020

Primary Completion Date

December 17, 2024

Completion Date

December 17, 2024

Last Updated

December 31, 2025

Enrollment

ACTUAL participants

Conditions

Thyroid Eye Disease

Interventions

Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept

DRUG

Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept

DRUG

Sub-tenon injection of hyaluronidase (HA) alone

DRUG

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

NCT06112340

Thyroid Eye DiseaseGraves Orbitopathy+10 more

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RECRUITINGNA

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

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Thyroid Eye Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Anti-VEGF Therapy for Acute Thyroid Eye Disease

Inclusion Criteria

Exclusion Criteria

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)