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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
EU CTIS ID: 2023-504655-27-00
What this study is testing
To determine the efficacy and safety of bel-sar compared to sham control for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) with documented early growth
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naïve for their IL/CM (Note: eligibility for subjects who have received treatment with photodynamic therapy >6 months prior to enrollment should be discussed with the medical monitor for approval prior to enrollment).
You likely can't join if
- Any active eye infection or ocular disease in the study eye (other than IL/CM)
- Have known contraindications or sensitivities to the study drug or laser
- Have a history of any ocular surgery/procedure that could alter the SCS and affect the SC administration of study drug (e.g., scleral buckle, laser retinopexy, macular laser, or panretinal photocoagulation).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Israel
- Canada
- United States
- Australia
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Israel; Canada; United States; Australia; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.