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Anti-VEGF Therapy
Anti-VEGF Therapy for Thyroid Eye Disease (AcTED Trial)
Phase 2
Recruiting
Led By Nahoung Grace Lee, MD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Active Thyroid Eye Disease
Minimum of 18 years-old
Must not have
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study
Infectious conjunctivitis, keratitis, or endophthalmitis of either eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-90 days
Summary
This trial is testing the safety of injecting a medication called aflibercept, mixed with either a saltwater solution or an enzyme, around the eyes of patients with acute Thyroid Eye Disease. The goal is to see if this treatment can safely reduce swelling and inflammation. Patients will receive multiple injections and be monitored for any side effects. Aflibercept has been used in various retinal diseases, including macular edema and age-related macular degeneration.
Who is the study for?
This trial is for adults over 18 with active Thyroid Eye Disease, showing moderate symptoms. Participants must be able to consent and follow the study plan. Only one eye will be treated, preferably the worse one or non-dominant if equal. Exclusions include prior eye surgeries or treatments, other retinal issues, heart attack or stroke history, aflibercept allergy, infections in the eye area, certain device implants in the eye, recent participation in other drug studies or radiation exposure research.
What is being tested?
The trial tests safety and tolerability of aflibercept injections for acute Thyroid Eye Disease when combined with saline or hyaluronidase (HA), compared to HA alone. Over a period leading up to day 45 from baseline, participants receive three injections while undergoing clinical examinations to monitor adverse events.
What are the potential side effects?
Potential side effects may include discomfort at injection site, inflammation within the eye area due to immune response against VEGF inhibition by aflibercept; allergic reactions are possible especially given known hypersensitivity exclusions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with active Thyroid Eye Disease.
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I am at least 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am sexually active and not willing to use birth control during the study.
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I have an eye infection.
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I have a condition affecting my optic nerve that threatens my vision.
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I am not currently using steroids, or if I was, I've stopped for at least 6 weeks.
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I have been treated with drugs targeting blood vessel growth in cancer.
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I've had HA injections for my thyroid eye disease.
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I have previously used Tepezza for treatment.
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I have had a stroke or heart attack before.
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I have eye conditions like diabetic retinopathy that could change VEGF levels in my eye.
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I have had surgery or radiation on my eye area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
: Safety
Secondary study objectives
: Change in Clinical Activity
: Change in Eyelid Retraction/Position
: Change in Ocular Alignment
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Saline and afliberceptExperimental Treatment1 Intervention
Group 1: Sub-tenon's injection of saline followed by sub-tenon injection of aflibercept
Group II: Hyaluronidase and afliberceptExperimental Treatment1 Intervention
Group 2: Sub-tenon's injection of hyaluronidase (HA) followed by sub-tenon injection of aflibercept
Group III: Hyaluronidase alonePlacebo Group1 Intervention
Group 3: Sub-tenon injection of HA injection alone
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Graves' Ophthalmopathy treatments often focus on reducing inflammation and abnormal tissue growth around the eyes. Anti-VEGF agents like aflibercept inhibit vascular endothelial growth factor, which decreases inflammation and vascular permeability.
This is important for patients as it directly addresses the underlying inflammatory processes and abnormal blood vessel formation, potentially reducing symptoms such as proptosis and vision impairment, and improving overall disease outcomes.
Short-term efficacy of intravitreal aflibercept in treatment-naive patients with polypoidal choroidal vasculopathy.Vascular endothelial growth factor acts primarily via platelet-derived growth factor receptor α to promote proliferative vitreoretinopathy.
Short-term efficacy of intravitreal aflibercept in treatment-naive patients with polypoidal choroidal vasculopathy.Vascular endothelial growth factor acts primarily via platelet-derived growth factor receptor α to promote proliferative vitreoretinopathy.
Find a Location
Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
109 Previous Clinical Trials
12,659 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,819 Total Patients Enrolled
Nahoung Grace Lee, MDPrincipal InvestigatorInvestigator
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am sexually active and not willing to use birth control during the study.I have been diagnosed with active Thyroid Eye Disease.I have an eye infection.I am at least 18 years old.I have a condition affecting my optic nerve that threatens my vision.You have a glaucoma device implanted under the surface of your eye.I am not currently using steroids, or if I was, I've stopped for at least 6 weeks.I have been treated with drugs targeting blood vessel growth in cancer.I've had HA injections for my thyroid eye disease.I have previously used Tepezza for treatment.You have been in another research study in the last year that involved getting CT scans (not MRIs).I have had a stroke or heart attack before.I have eye conditions like diabetic retinopathy that could change VEGF levels in my eye.Your clinical activity score is between 3 and 5.I have had surgery or radiation on my eye area.You are allergic to aflibercept.I have received eye injections for VEGF within the last year.My natural lens is intact or I have a lens implant in my eye.
Research Study Groups:
This trial has the following groups:- Group 1: Saline and aflibercept
- Group 2: Hyaluronidase and aflibercept
- Group 3: Hyaluronidase alone
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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