RecruitingPHASE3INTERVENTIONAL

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

This research is looking at a new treatment called bel-sar for people with a type of eye tumour called choroidal melanoma, or for mysterious spots in the eye that doctors can’t quite explain. These spots are called indeterminate lesions and sometimes turn into melanoma. The study is a "Phase 3" trial, which means it’s one of the final steps before a new treatment might become widely available if it works well. Doctors want to find out if bel-sar is safe and effective when compared to a dummy treatment (sham control). They'll be looking to see if it can help stop these eye conditions from growing or getting worse. This is an important step to find new ways to treat these eye problems and protect people's vision.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Aura Biosciences

Enrolment target

100

Start

06 Dec 2023

Estimated completion

15 Aug 2028

Choroidal Melanoma Indeterminate Lesions Uveal Melanoma Ocular Melanoma

What is this study about?

This study is investigating a new treatment named bel-sar for a specific type of eye tumour called choroidal melanoma, or for certain unclear spots in the eye known as indeterminate lesions. Choroidal melanoma is a rare form of cancer that develops in the eye, and indeterminate lesions are spots that doctors watch closely because they could potentially develop into melanoma. Finding effective and safe ways to treat these conditions is really important to help protect people's eyesight and overall health.

The main goal of this study is to see how safe and effective bel-sar is compared to a 'sham' treatment. A sham treatment is like a dummy treatment – it goes through the same steps but doesn't contain the active drug. This helps doctors fairly compare the new treatment's effects. The bel-sar treatment involves giving a special drug using a very small device that injects it into a specific part of the eye, followed by using a special laser to activate the drug. Participants, doctors, and the people analysing the results won't know who is getting the real treatment and who is getting the sham, to make sure the findings are unbiased.

By taking part, you could be helping doctors learn more about how to treat these eye conditions. This knowledge could lead to better treatments for people in the future. The study is carefully designed to check both the safety of bel-sar and whether it can effectively stop the eye condition from growing or getting worse.

Key takeaways

This study is for a new treatment for eye cancer (choroidal melanoma) or suspicious eye spots.
It's a 'Phase 3' trial, which means it's an advanced stage of testing.
The treatment called bel-sar involves an injection and a special laser.
Some people will get the active treatment, others a dummy treatment, chosen randomly.
The aim is to check if bel-sar is safe and if it helps stop the eye condition from getting worse.

Who may be eligible?

To be considered for this study, you would need to have received a diagnosis of an indeterminate lesion or a small choroidal melanoma in your eye. It's really important that these eye conditions are newly diagnosed and that you haven't received any previous treatment for them, although if you had a specific type of laser treatment called PDT, you might still be able to join. Also, doctors need to confirm that the condition hasn't spread to other parts of your body through special scans.

There are also some reasons why you might not be able to join. For example, if you have allergies or react badly to certain medicines or the type of laser used in the study, unfortunately, you wouldn't be able to participate. Similarly, if you have any active eye infections or other eye diseases that could interfere with the study treatment, you wouldn't be eligible. Everyone taking part must be 18 years old or older, and the study is open to both men and women.

Quick self-check

Do I have a newly diagnosed indeterminate lesion or small choroidal melanoma?
Have I had scans to confirm the condition has not spread?
Am I at least 18 years old?
Do I have any active eye infections or other serious eye problems?
Do I have any known allergies to medicines or lasers?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will explain everything in detail. You would receive the study treatment, which involves a special drug given into your eye using a small device, followed by a laser session to activate the drug. Some participants will receive the active bel-sar treatment, while others will receive a 'sham' treatment, which looks the same but doesn't contain the active drug. Neither you nor your doctor would know which one you're getting, to ensure the study results are fair.

You would have regular visits to the clinic so the study team can monitor your eyes closely, check how you're feeling, and assess the treatment's effect. These visits will include eye examinations, vision tests, and possibly scans. You might also have blood tests. The study team will explain how often these visits will be and what they involve. The total length of your participation in the study, including follow-up appointments, would be clearly outlined before you agree to join.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might help your eye condition, which may not be available outside of a trial. However, there's no guarantee the treatment will work for you, and like all medical treatments, bel-sar may have side effects or risks. These could include temporary discomfort, changes in vision, or other reactions in your eye. The study team will explain all known potential side effects and risks in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (71)

Retina Consultants of Alabama
Birmingham, United States· Withdrawn
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, United States· Recruiting
Doris Stein Eye Research Center
Los Angeles, United States· Recruiting
Stanford University School of Medicine
Palo Alto, United States· Recruiting
Retinal Consultants Medical Group, Inc.
Sacramento, United States· Recruiting
Bascom Palmer Eye Institute
Miami, United States· Withdrawn
Retina Associates of Florida, PA
Tampa, United States· Recruiting
Emory Eye Center
Atlanta, United States· Recruiting
University of Illinois at Chicago
Chicago, United States· Recruiting
Tufts Medical Center New England Eye Center
Boston, United States· Recruiting
Massachusetts Eye and Ear
Boston, United States· Recruiting
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, United States· Recruiting

+59 more sites — see the official record for the full list.

Common questions

What is choroidal melanoma?

Choroidal melanoma is a rare type of cancer that develops in a part of the eye called the choroid, which is behind the retina.

What are indeterminate lesions?

These are unclear spots in the eye that doctors watch closely because they might, in some cases, develop into choroidal melanoma.

What does 'sham control' mean?

A sham control means some people will have a procedure that looks and feels like the real treatment but doesn't involve the actual drug. This helps scientists compare results fairly.

How is bel-sar given?

Bel-sar is given using a tiny device that injects the drug into a specific area of your eye, followed by a special laser to activate it.

Can I choose which treatment I get?

No, participants are randomly assigned to either the bel-sar treatment or the sham control. Neither you nor your doctor will know which one you receive.

How to find out more

Medical Monitor

clinical@aurabiosciences.com 617-500-8864 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.