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Anti-VEGF Therapy for Thyroid Eye Disease (AcTED Trial)
AcTED Trial Summary
This trial is testing a new treatment for Thyroid Eye Disease that involves injecting a drug called aflibercept into the space around the eye. The trial will assess the safety and tolerability of this treatment by looking at the incidence and severity of adverse events from baseline to day 45.
AcTED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAcTED Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AcTED Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Saline and aflibercept
- Group 2: Hyaluronidase and aflibercept
- Group 3: Hyaluronidase alone
- 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.
Frequently Asked Questions
What are the risks associated with a Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept?
"Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept is classified as a phase 2 trial, which means that while there is data supporting its safety, none exists for efficacy. We therefore rate it as a 2."
Is this the first instance of using Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept in clinical trials?
"As of right now, 57 clinical trials are underway that focus on Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept. Out of those 57 trials, 25 are currently in Phase 3. Although the majority of studies for this treatment are based in Lebanon and New hampshire, there are actually 2266 locations running these kinds of studies."
Are new participants being accepted into this research program?
"The latest information from clinicaltrials.gov tells us that this study is still looking for patients. The trial was originally posted on November 2nd 2020, with the February 8th update being the most recent change."
How many people are allowed to be part of this clinical trial at one time?
"Yes, this is an ongoing study that has been recruiting since November 2nd 2020. The trial takes place at a single site and is looking for 24 patients in total."
What is the usual purpose of combining these two injections?
"One common treatment for retina central vein structure is a Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept. This method is also successful in treating other conditions like increased absorption and dispersion of other injected drugs, urography, and parenteral drug administration therapy."
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