A Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions/Small Choroidal Melanomas)
Choroidal melanoma is a rare type of cancer that develops in the back of the eye. Traditional treatments often damage eyesight. This long-term follow-up study monitors adults who already completed an earlier clinical trial (the CoMpass study) testing a new drug called bel-sar (belzupacap sarotalocan). Because cancer treatments can have effects that show up years later, researchers need to follow patients over time. In this study, doctors will check whether the eye tumour has grown, whether the cancer has spread, and how well participants can still see. They will also track any ongoing or new side effects. No new study drug is given during this follow-up phase. The goal is to learn if bel-sar is safe and effective in the long run, helping doctors improve future eye cancer treatments while saving patients' sight.
At a glance
What is this study about?
Choroidal melanoma is a rare cancer that starts in the pigmented cells inside the eye. Finding it early gives the best chance of treating it, but current standard treatments, such as radiation therapy, can often lead to permanent vision loss. Researchers have been testing an experimental medicine called belzupacap sarotalocan (bel-sar), which aims to treat the tumour while protecting your sight.
This specific study is a long-term follow-up. It is designed for patients who have already finished taking part in the main 'CoMpass' clinical trial. Because eye tumours can return or grow very slowly, and side effects can sometimes take months or years to appear, doctors need to keep monitoring participants over an extended period.
During this study, researchers will closely track your eye health and general wellbeing. They want to see whether the tumour remains controlled, whether your eyesight stays stable, and whether any delayed side effects occur. They will also watch for any signs of the cancer spreading beyond the eye.
Taking part in long-term research like this is vital. It gives doctors the complete picture of how well new treatments work over a lifetime, helping ensure that future patients receive therapies that are both safe and effective at saving their sight.
Key takeaways
- This study tracks the long-term health of people who completed the CoMpass trial for choroidal melanoma.
- No new study drugs or injections are given during this follow-up phase.
- The main goals are to check tumour control, long-term safety, and sight preservation.
- Participants attend regular specialist eye checks and scans over several years.
- Joining is voluntary, and you can withdraw at any point without affecting your standard care.
Who may be eligible?
This study is only open to adults aged 18 and older who have already taken part in and completed the main AU-011-301 (CoMpass) clinical trial. Men and women are both eligible.
Because this is an extension study, you cannot join if you were not enrolled in the original CoMpass trial. Your study team will review your records to confirm you completed all required steps of the previous study before you move into this follow-up phase.
There are no new health hurdles to jump over, but you must be willing to continue attending scheduled check-ups so doctors can monitor your eyes and overall health over time.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I was enrolled in and completed the AU-011-301 (CoMpass) clinical trial.
- I am willing to attend regular eye check-ups over the next few years.
- I agree to let doctors monitor my vision and tumour measurements.
What does participation involve?
Because this is a follow-up study, you will not receive any new study drug or sham injections. Instead, taking part involves attending regular hospital visits so eye specialists can monitor your health.
During these appointments, doctors will check your vision using standard eye charts and take detailed pictures or scans of the back of your eye. These tests measure the thickness and size of the tumour to make sure it is not growing. The team will also ask about your general health, check for any delayed side effects, and check whether you have needed any other treatments for your eye.
Visits are spaced out over several years. Your study doctor will explain the exact schedule and how long you will be followed, ensuring you understand each step of the journey.
Potential risks and benefits
Locations (8)
- —UnverifiedAustria
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
Will I receive any new medication during this study?
No. This is a follow-up study to monitor your health after the main trial. You will not receive any new trial medicines or injections.
Do I have to take part if I was in the original CoMpass trial?
No. Taking part is entirely your choice. If you decide not to join, your normal medical care will continue as usual.
Will these visits cost me anything?
Clinical trial visits and study-related tests are provided at no cost to you. Many studies also offer help with travel expenses.
What happens if my tumour starts to grow again?
If your eye scans show any tumour growth, your doctor will discuss standard treatment options with you right away to protect your health.
Can I leave the study early if I change my mind?
Yes. You can withdraw your consent at any time without giving a reason, and your regular eye care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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