USC Roski Eye Institute conducts clinical trials for thyroid eye disease treatment

The USC Roski Eye Institute is at the forefront of clinical trials exploring new medications to treat Thyroid Eye Disease (TED), a condition that causes the eyes to bulge and can lead to vision loss, double vision, and other complications.

TED occurs when the muscles and fatty tissue behind the eye expand beyond what the eye socket can normally contain, pushing the eyeball forward. Sandy Zhang-Nunes, MD,  an oculoplastic surgeon and principal investigator of the TED clinical trials at USC, explains that TED traditionally required multiple invasive surgeries.

“Traditionally, when treating TED, oculoplastic surgeons would do orbital decompression surgery, meaning they would go around the eye and remove excess bone and fat to give more space for the eye to sink back into a normal position,” said Zhang-Nunes. “Then our strabismus colleagues would become involved to do eyelid surgery for double vision if needed. Eyelid surgery is often still needed as a third step.”

Prior to a few years ago, no medication for TED was available. However, the emergence of new drugs has opened the possibility of treating the underlying biology of TED without surgery. “New medications coming out mean the potential for less surgery, and even if surgery is still needed, it’s typically an easier surgery. It’s better for the patient.”

At Roski, Zhang-Nunes and her team are currently conducting three separate clinical trials for TED, with more in the pipeline. The first study tested three different dosages of an infusion medication already approved by the Food and Drug Administration (FDA) for patients diagnosed with TED within the past 12 months. Participants received eight infusions every three weeks and were evaluated over 52 weeks. A subcutaneous version of this drug will be tested in the near future.

The second study involves a different drug with a similar mechanism for five doses of the drug every three weeks.  This high disease activity study recently closed enrollment, but a second study for longer disease duration and lower disease activity for TED patients is still recruiting.

A third study involves an infusion of a drug with different mechanism acting on a completely different receptor for immune modulation. Another future study will involve oral therapy for TED. Researchers working with Dr. Zhang-Nunes are further evaluating the safety and efficacy of these medications for TED patients.

“We want to see if these TED investigational medications work on improving proptosis, or bulging around the eye, that TED patients tend to experience,” said Ricardo Montoya, the Clinical Research Coordinator at Roski’s clinical trials team. “Does it have fewer side effects? That’s the goal, for our patients to experience less side effects and improve the quality of their life as well as their vision.”

Zhang-Nunes emphasizes the importance of individualized treatment plans, as side effects may vary among patients. The availability of multiple options for medications allows for a more personalized approach to managing TED for each patient. “These trials help us advance science and find the best treatments for our patients,” said Zhang-Nunes.

With promising results from these clinical trials, the USC Roski Eye Institute plans to continue recruiting participants for future trials, advancing the search for effective and minimally invasive treatments for Thyroid Eye Disease.