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Long‑Term Follow‑Up Study of Belzupacap Sarotalocan in Patients with Early Choroidal Melanoma

Verified siteInvestigational
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Choroidal Melanoma, a rare type of cancer that forms in the pigmented layer at the back of the eye and can affect vision. Participants receive an injection into the eye containing the investigational drug Bel-sar, which is designed to target early tumors, or a sham injection known as a placebo. The treatment is given as a small amount of liquid that is administered directly to the eye.

The purpose of the study is to determine whether the drug remains safe and effective over a long period after the initial treatment. After completing the earlier trial, participants return for regular check‑ups that include eye examinations, imaging of the tumor, and assessments of vision and overall health. These visits continue for several years to monitor any changes in the tumor, side effects, and vision outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study, you will sign a consent form that explains the purpose of the long‑term follow‑up and what will be required of you.

    The research team will confirm that you have completed the previous au‑011‑301 trial and meet the eligibility criteria for the follow‑up.

  2. Step 2

    Baseline assessment

    A comprehensive eye examination will be performed, including imaging of the choroidal melanoma and measurement of visual acuity using the etdrs chart.

    The results will serve as the reference point for all future comparisons.

  3. Step 3

    Review of previous medication

    The study medication, bel‑sar (belzupacap sarotalocan), was given as a single ocular injection of 80 µg in a solution for injection during the original trial.

    No additional doses are scheduled during the long‑term follow‑up, but the previous dose will be considered when evaluating safety and effectiveness.

  4. Step 4

    Regular follow‑up visits

    You will attend scheduled visits, typically every six months, for up to several years.

    Each visit includes an eye exam, imaging to assess tumor size and thickness, and a visual acuity test to detect any loss of vision.

    The team will record any new symptoms, side effects, or changes in health.

  5. Step 5

    Monitoring for adverse events and disease progression

    Any occurrence of adverse events (unwanted medical problems) or signs of tumor progression will be documented.

    The study will track the time until tumor growth, vision loss of 15 letters or more, and any need for additional eye treatments.

    Information collected will help determine the long‑term safety and efficacy of bel‑sar.

Who can join the trial?

6 criteria

  • Have already received bel-sar (the study drug) or a sham treatment (a placebo‑like procedure) in the earlier Aura trial called AU-011-301.
  • Be willing and able to give written consent (agree to take part) for the new study named AU-011-403.
  • Be a patient with choroidal melanoma, the condition the trial is studying.
  • Be any gender (both men and women are allowed to join).
  • Be in the age groups that the study includes (the study lists age codes 3 and 4, which correspond to the approved age range for participants).
  • Be considered a vulnerable individual if applicable, as the trial permits participation of vulnerable participants with appropriate protections.

Who cannot join the trial?

1 criterion

  • None
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Investigated drugs

BELZUPACAP SAROTALOCAN is an experimental medicine given as a sterile liquid that is injected directly into the eye. It is being studied to treat early choroidal melanoma, which are small or uncertain‑looking tumors located at the back of the eye. The drug is designed to target these tumors while minimizing damage to surrounding eye tissue. Because choroidal melanoma is a rare condition, this medication is classified as an orphan drug. In this long‑term follow‑up study, participants who received the injection are monitored over several years to check that the treatment remains safe and to see if it continues to prevent the tumors from growing or spreading.

What is already known about the treatment

BELZUPACAP SAROTALOCAN - This medication is supplied as a sterile solution for injection and is administered directly into the eye at a dose of 80 µg. It is an orphan drug that is still under investigation and has not yet received market approval. The drug is being studied for the treatment of early choroidal melanoma, a rare cancer of the eye. It works by attaching to tumor cells and, when activated by a specific light source, helps the immune system destroy those cells, placing it in the photo‑immunotherapy class of medicines.

Investigated diseases

Choroidal Melanoma - Choroidal melanoma is a cancer that originates from pigment‑producing cells in the choroid, the vascular layer at the back of the eye. The tumor typically begins as a small pigmented lesion and slowly enlarges over months to years. As it grows it can thicken the retina and distort the underlying structures, leading to visual disturbances. In later stages the cancer can break through the eye wall and spread through the bloodstream, most commonly to the liver. The disease course varies, but unchecked growth can result in local invasion and distant metastasis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524405-33-00Protocol codeAU-011-403Estimated enrolment99 patientsSponsorAura Biosciences Inc.

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