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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • None

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Graz Graz Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nice Nice France
Cdltexcam Uhgzdunujasolv Scifnjhnk Woluwe-Saint-Lambert Belgium
Fxyjpmva Nybdkoomi Pjhio Plzen Czechia
Upauacwm Vlvaofpm Njrpdrwne Vhpwithv Fxwmscwl Nttjcxvuy Pdfpo Prague Czechia
Fjwaqqlb Tyozjogzlgj ngdmmaxaj Prague Czechia
Uhgteclezkdv Di Srczjpzk Dy Cpwelqxtkf Santiago De Compostela Spain
Ctvwrv Hecomzeolbx Lwwv Slj Pierre Benite France
Cgmstsz Ufevvnckmcaewfwgzeob Bwiorl Kom Berlin Germany
Ekqpekm Uqmswdlrqcrn Msclnyj Cgquzzm Rtrmwogrs (dclawsx Mwc Rotterdam The Netherlands
Kpjykvzs dcc Udruexkgmnnr Mglfyfer Akk Munich Germany
Ucpelmzmfn Meayvhp Cnuzii Hnnjjzcrdsodgosfq Hamburg Germany
Ucchkhzbcjgwayphcdgeq Ewagz Apa Essen Germany
Ltvvb Umbtjnvydttd Mcstzve Ctavvwx (pgurg Leiden The Netherlands
Aztp Fsopbyoymcemmwqm Sndee Milan Italy
Ftwhuamxcm Inmxbumqwe Iyxembpe Npjkolewxuk Banrf Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
17.02.2027
Belgium Belgium
Not yet recruiting
17.02.2027
Czechia Czechia
Not yet recruiting
17.02.2027
France France
Not yet recruiting
17.02.2027
Germany Germany
Not yet recruiting
17.02.2027
Italy Italy
Not yet recruiting
17.02.2027
Spain Spain
Not yet recruiting
17.02.2027
The Netherlands The Netherlands
Not yet recruiting
17.02.2027

Trial locations

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.

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 ID:
2025-524405-33-00
Protocol code:
AU-011-403
NCT ID:
NCT07338968
Trial Phase:
Therapeutic confirmatory (Phase III)

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