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
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).
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.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06007690
Intervention or treatment
DRUG: Bel-sar
DEVICE: Suprachoroidal Microinjector
DEVICE: Infrared Laser
DEVICE: Sham Infrared Laser
DEVICE: Sham Microinjector
Conditions
- Choroidal Melanoma
- Indeterminate Lesions
- Uveal Melanoma
- Ocular Melanoma
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Terrace Eye Centre
Select from list below to view details:
Terrace Eye Centre
Brisbane, Queensland, Australia
Eye Research Australia
East Melbourne, Victoria, Australia
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Who is running the clinical trial?
Aura Biosciences
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
| Drug: Bel-sar, Device: Suprachoroidal Microinjector, Device: Infrared Laser |
EXPERIMENTAL: Low dose bel-sar treatment arm & laser application
| Drug: Bel-sar, Device: Suprachoroidal Microinjector, Device: Infrared Laser |
SHAM_COMPARATOR: Sham control arm & sham laser
| Device: Sham Infrared Laser, Device: Sham Microinjector |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach tumor progression | Tumor Progression | 65 weeks |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Time to composite endpoint | Tumor progression or visual acuity failure | 65 weeks |
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 MelanomaOther trials to consider
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