Under the leadership of principal investigator Timothy Fuller, MD, Texas Retina is now participating in the Phase III AU-011 clinical trial (CoMpass) for treatment of small choroidal (ocular) melanoma. Together with Aura Biosciences, we are investigating the safety and efficacy of belzupacap sarotalocan (AU-011), a light-activated viral nanoparticle, in the treatment of this rare and often deadly cancer.

Texas Retina previously participated in the Phase II trial where Dr. Timothy Fuller was the first in the nation to treat a patient with AU-011 delivered via suprachoroidal injection. Following injection, the tumor is treated with a special ophthalmic laser to activate the viral nanoparticles to selectively destroy the tumor. All of this is done in an outpatient, office-based setting.

In the Phase III trial, patients will be randomized to receive a high-dose regimen of AU-011, a low-dose regimen, or sham control. The study’s primary endpoint is time to tumor progression. Inclusion criteria include:

  • Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  • Have no evidence of metastatic disease confirmed by imaging
  • Be treatment naive for IL/CM (subjects who received photodynamic therapy/PDT may be eligible)

Exclusion criteria include known contraindications or sensitivities to the study drug or laser and/or active ocular infection or disease.

Striving to Improve Care for Patients with Ocular Melanoma
For decades, the standard of care for all choroidal melanoma had been eye removal (enucleation), until the Collaborative Ocular Melanoma Study (COMS) came about in the 1980s. These multi-center, randomized controlled trials, also pioneered at Texas Retina Associates by Principal Investigator Dwain Fuller, MD, showed the efficacy of treating choroidal melanoma with radiation treatment (known as plaque brachytherapy). While brachytherapy revolutionized how this type of cancer is treated, it unfortunately almost always comes with vision loss. With AU-011, we are investigating the potential to treat this deadly disease with less harmful effects on vision. AU-011 has been shown in prior studies to selectively destroy cancer membrane cells while sparing the overlying retina, a tissue essential for good vision.

It is important for all people to have regular dilated eye exams to screen for suspicious lesions and ocular melanoma. While the disease is more likely to affect those with lighter skin and eyes, it has been seen in patients of all ethnicities and backgrounds. Talk to your comprehensive eye care provider or Texas Retina physician if you have any questions. Click here for details on this clinical trial as well as a full listing of our current clinical trials.