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Examining a New Treatment for Small Eye Tumors in a Clinical Trial

NCT06007690 · Recruiting
About this trial

This trial is looking at how well a new treatment called belzupacap sarotalocan works for people with small choroidal melanoma or indeterminate lesions. The main goal is to see how safe and effective this treatment is compared to a sham (fake) procedure. Participants will receive the treatment through a special injection followed by laser activation.

Locations and contact

This trial is running at 71 locations. The first 8 are listed here.

  • Retina Consultants of AlabamaBirmingham, AlabamaWithdrawn
  • UCSD Shiley Eye Institute, Jacobs Retina CenterLa Jolla, CaliforniaRecruiting
  • Doris Stein Eye Research CenterLos Angeles, CaliforniaRecruiting
  • Stanford University School of MedicinePalo Alto, CaliforniaRecruiting
  • Retinal Consultants Medical Group, Inc.Sacramento, CaliforniaRecruiting
  • Bascom Palmer Eye InstituteMiami, FloridaWithdrawn
  • Retina Associates of Florida, PATampa, FloridaRecruiting
  • Emory Eye CenterAtlanta, GeorgiaRecruiting
See all 71 locations →
Who to ask about joining
Who can join

Adults aged 18 and older can join the trial. It is open to both men and women. People must have a clinical diagnosis of small choroidal melanoma or indeterminate lesions. They should not have evidence of any spread of the disease. Those who have had certain treatments for this condition may still be eligible. Some people cannot join if they have allergies to the study drug or laser, or if they have an active eye infection or disease. The trial team will confirm who is eligible.

What happens during the trial

Participants will be placed into different groups by chance. Some will receive a high dose of the new treatment and laser application. Others will get a low dose of the same treatment with laser application. There is also a group receiving a sham injection and a sham laser treatment. Everyone will have a chance to receive either type of treatment during the study.

The trial team

Aura Biosciences is running this trial. They are the lead organization and are responsible for the study. The Medical Monitor from Aura Biosciences is the study director overseeing the trial.

Important dates

The trial started on December 6, 2023. It is currently enrolling new participants. The primary part of the study is expected to finish by November 15, 2027, and the overall study should be completed by August 15, 2028.

Additional information

The trial's ID number is NCT06007690. It is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. This trial is regulated by the FDA and aims to include about 100 participants.

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Examining a New Treatment for Small Eye Tumors in a…