Patients with ocular melanoma, a type of melanoma that develops in the eye, have a potentially new and groundbreaking treatment option being assessed in a Phase 1 clinical trial.
The trial (NCT03052127), which is being conducted at Wills Eye Hospital in Philadelphia, will test the light-activated drug AU-001 in small to medium primary ocular melanoma patients who have not received prior treatment.
“Patients with ocular melanoma currently have few treatment options available that can effectively destroy tumor cells while preserving vision. Conducting valuable research trials like this one enables clinicians and researchers to examine new and better options for patients throughout the world,” Carol L. Shields, MD, co-director of Ocular Oncology Service at Wills Eye Hospital, said in a press release.
Shields is a leader in the field of ocular melanoma and a key investigator in the research trial.
Ocular melanoma, a rare and life-threatening type of cancer, affects nearly 3,000 people every year in the U.S. Patients usually have no symptoms, which largely hampers cancer detection before it spreads to other areas of the body. The best way to detect ocular melanoma is to have annual eye exams performed by board-certified ophthalmologists.
Plaque radiotherapy, a type of radiation therapy in which a thin piece of metal with radioactive seeds is sewed in the outside wall of the eye, is the current first-line treatment for ocular melanoma patients. While the approach has been successful in controlling tumor growth, researchers believe that AU-011 may be less invasive and potentially allow patients to preserve their vision.
AU-011 is designed to destroy the membranes of the ocular melanoma while sparing key eye structures. The drug consists of viral nanoparticle conjugates that are injected in the patient’s eye, but only become activated when an ophthalmic laser sheds light on the particles, ensuring that only cancer regions are affected by the drug.
“We are delighted to be one of the preeminent clinical trial sites in the nation for this unique and promising treatment,” said Julia A. Haller, MD, ophthalmologist-in-chief at Wills Eye Hospital. “Wills Eye has always been a leader in the clinical application of emerging new therapies. We are 100 percent behind our world’s best oncology team.”
The trial, which will be investigating the safety and preliminary activity of two dose levels of AU-011, began earlier this year and is set to enroll up to 12 patients, who will be followed for two years after receiving the treatment.