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Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Bel-sar (drug), Suprachoroidal Microinjector (device), Infrared Laser (device), Sham Infrared Laser (device)
How long the study runs: Study runs about 56 months (dates as stated)
About the drug or intervention: Bel-sar — drug: Bel-sar via suprachoroidal administration followed by laser application. · Suprachoroidal Microinjector — device: Suprachoroidal injection device · Infrared Laser — device: Laser application · Sham Infrared Laser — device: Sham laser application · Sham Microinjector — device: Sham injection device
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 108
Started: 2023-12-06
Last checked: 2026-07

Plain English Summary

What is this study?

• Testing a new treatment for choroidal melanoma
• Phase3 - 108 participants
• The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM)

Who can take part?

• Ages 18 Years and over
• Diagnosed with choroidal melanoma

Where?

• London - Moorfields Eye Hospital NHS Foundation Trust
• Sheffield - Nhs Foundation Trust - Royal Hallamshire Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

More detail

This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

What the study is looking for

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

Who cannot take part

✗Have known contraindications or sensitivities to the the study treatment or laser
✗Active ocular infection or disease

See the full criteria

Inclusion Criteria: * 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 PDT may be eligible) Exclusion Criteria: * Have known contraindications or sensitivities to the study drug or laser * Active ocular infection or disease

Where Is This Study? (2 UK sites)

Moorfields Eye Hospital NHS Foundation Trust

London EC1V 2PD, United Kingdom

Hospital R&D contact (matched)

Research Portfolio Managers- Daniela Narvaez, Anika Kadchha, Abi Chandrakumar, Xin Liu

moorfields.resadmin@nhs.net 0207 566 2036

Nhs Foundation Trust - Royal Hallamshire Hospital

Sheffield S10 2JF, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-07