RECRUITING

Anti-VEGF Therapy for Acute Thyroid Eye Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-02

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04311606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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:	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)

Inclusion Criteria

Exclusion 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:

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)

Contacts and Locations

Study Contact

Nahoung Grace Lee, MD

CONTACT

617-572-5550

Grace_Lee@MEEI.HARVARD.EDU

Yuki A Wiland, BS

CONTACT

617-573-6060

yuki_wiland@meei.harvard.edu

Principal Investigator

Nahoung Grace Lee, MD

PRINCIPAL_INVESTIGATOR

Investigator

Study Locations (Sites)

Mass Eye and Ear

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

Nahoung Grace Lee, MD, PRINCIPAL_INVESTIGATOR, Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-02

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2020-11-02

Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

VEGF

Additional Relevant MeSH Terms

Thyroid Eye Disease