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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

PHASE3RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-12-06

Primary completion: 2026-03-01

Study completion finish: 2027-03-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06007690

Intervention or treatment

DRUG: Bel-sar

DEVICE: Suprachoroidal Microinjector

DEVICE: Infrared Laser

DEVICE: Sham Infrared Laser

DEVICE: Sham Microinjector

Conditions

• Uveal Melanoma
• Choroidal Melanoma
• Indeterminate Lesions
• Ocular Melanoma

Condition: Uveal Melanoma, Choroidal Melanoma and more
DRUG: Bel-sar and other drugs
Brisbane, Queensland, Australia and more
Sponsor: Aura Biosciences

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Terrace Eye Centre

Research sites nearby

Select from list below to view details:

Terrace Eye Centre
Brisbane, Queensland, Australia
Eye Research Australia
East Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: High dose bel-sar treatment arm & laser application High dose of bel-sar + laser application	DRUG: Bel-sar Bel-sar via suprachoroidal administration followed by laser application.
EXPERIMENTAL: Low dose bel-sar treatment arm & laser application Low dose of bel-sar + laser application	DRUG: Bel-sar Bel-sar via suprachoroidal administration followed by laser application.
SHAM_COMPARATOR: Sham control arm & sham laser Sham injection + sham laser	DEVICE: Sham Infrared Laser Sham laser application

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Time to reach tumor progression	Tumor Progression	65 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Time to composite endpoint	Tumor progression or visual acuity failure	65 weeks

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: 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