Study on the Effectiveness and Safety of Belzupacap Sarotalocan for Patients with Small Choroidal Melanoma or Indeterminate Lesions

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What is this study about?

This clinical trial is focused on studying the treatment of Primary Indeterminate Lesions or Small Choroidal Melanoma, which are conditions affecting the eye. The treatment being tested is called Belzupacap Sarotalocan, also known by its code name AU-011. This medication is administered as a solution for injection using a special device called the Clearside SCS Microinjector, which delivers the medication into a specific part of the eye known as the suprachoroidal space.

The purpose of this study is to evaluate the effectiveness and safety of Belzupacap Sarotalocan compared to a placebo, which is a sham injection that does not contain the active medication. Participants in the study will receive either the active treatment or the placebo. The study will monitor the participants over a period to assess how the treatment affects the progression of the eye condition.

Throughout the study, participants will undergo regular check-ups to track the condition of their eye and overall health. The study aims to determine how well the treatment works in slowing down or stopping the growth of the lesions or melanoma, as well as ensuring that it is safe for use. The trial is expected to continue until 2027, with recruitment starting in 2024.

1 joining the study

Upon joining the study, the patient is randomly assigned to receive either the belzupacap sarotalocan treatment or a placebo. The assignment is masked, meaning neither the patient nor the healthcare providers know which treatment is being administered.

2 treatment administration

The treatment involves the administration of belzupacap sarotalocan as a solution for injection. The injection is given through the suprachoroidal route, which is a method of delivering medication to the back of the eye.

If assigned to the placebo group, the patient receives a sham injection, which contains no active medication.

3 monitoring and follow-up

The patient is monitored regularly to assess the efficacy and safety of the treatment. This includes checking for any changes in the size of the tumor and evaluating visual acuity.

The primary endpoint of the study is the time it takes for the tumor to progress, which is analyzed at Week 65. Secondary endpoints include a composite measure of tumor progression or visual acuity failure, also assessed at Week 65.

4 completion of the study

The study is estimated to conclude by January 1, 2027. Throughout the study, the patient’s health and response to the treatment are closely monitored to ensure safety and gather data on the treatment’s effectiveness.

Who Can Join the Study?

  • Have a clinical diagnosis of primary indeterminate lesion or small choroidal melanoma with documented early growth. This means the patient has been diagnosed with a specific type of eye condition that is either uncertain or a small tumor in the eye, and there is proof that it has started to grow.
  • Have no evidence of metastatic disease confirmed by imaging. This means that tests, like scans, show that the disease has not spread to other parts of the body.
  • Be treatment naïve for their IL/CM. This means the patient has not received any treatment for their eye condition before. However, if they had a treatment called photodynamic therapy more than 12 months ago, they might still be eligible, but this needs to be discussed with a medical expert first.
  • Both male and female patients can participate.
  • Patients from vulnerable populations are also considered for participation.

Who Cannot Join the Study?

  • Patients with other eye diseases that could affect the study results.
  • Patients who have had previous treatments for eye tumors.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with uncontrolled medical conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name City Country Status
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha Prague Czechia
ASST Fatebenefratelli Sacco Milan Italy
St Erik Eye Hospital Solna Sweden
Fakultni Nemocnice Plzen Plzen Czechia
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nice Nice France
Mitera S.A. Athens Greece
Rigshospitalet Copenhagen Denmark
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Royal Victoria Eye And Ear Hospital Dublin Ireland
Crftnqhuy Utwdbjqnlblwgn Scamjdsxm Woluwe-Saint-Lambert Belgium
Uhopgfoqhp Meimoov Criugz Hzqdcrcegfgvglalx Hamburg Germany
Uxlnpcgunbiarypimsrqo Etvrp Aau Essen Germany
Lgmbj Uggqzztkmdvy Mckkktz Cxmkghm (fahxu Leiden The Netherlands
Ugqbghaldy Hyshiceo Ciisjew Cologne Germany
Evhylob Ucwdlkuwaiya Mtcmyyj Cgzmrsa Rzyeesrpk (byqplnq Myv Rotterdam The Netherlands
Kwhftqss ddi Uczvphcjxuse Msvxgdjd Aaw Munich Germany

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.04.2024
Belgium Belgium
Not recruiting
01.04.2024
Czechia Czechia
Not recruiting
01.04.2024
Denmark Denmark
Not recruiting
01.04.2024
France France
Not recruiting
01.04.2024
Germany Germany
Not recruiting
01.04.2024
Greece Greece
Not recruiting
01.04.2024
Ireland Ireland
Not recruiting
01.04.2024
Italy Italy
Not recruiting
01.04.2024
Spain Spain
Not recruiting
01.04.2024
Sweden Sweden
Not recruiting
01.04.2024
The Netherlands The Netherlands
Not recruiting
01.04.2024

Trial locations

Investigated drugs:

Belzupacap Sarotalocan (AU-011) is a medication being studied for its effectiveness and safety in treating primary indeterminate lesions and small choroidal melanoma, which are conditions affecting the eye. This medication is designed to target and destroy cancerous cells in the eye while sparing healthy tissue, potentially offering a new treatment option for patients with these specific eye conditions.

Primary Indeterminate Lesions or Small Choroidal Melanoma – This condition involves abnormal growths in the eye, specifically in the choroid, which is a layer of blood vessels between the retina and the sclera. These lesions are termed “indeterminate” because it is unclear whether they are benign or malignant. Small choroidal melanoma is a type of cancer that originates in the choroid and is characterized by its small size. The progression of this disease can lead to changes in the size and shape of the lesions, potentially affecting vision. Over time, these lesions may grow, leading to further complications within the eye. Monitoring is essential to determine if the lesions remain stable or progress to a more serious condition.

Trial ID:
2023-504655-27-00
Protocol code:
AU-011-301
NCT ID:
NCT06007690
Trial Phase:
Therapeutic confirmatory (Phase III)

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