Long-Term Check-In Study for Bel-sar Eye Cancer Treatment

In Plain English

If you participated in the AU-011-301 trial for early eye melanoma (a type of cancer in the back of your eye), this follow-up study invites you to continue being monitored for about 5 more years. This is not a treatment study—you won't receive any new medication or procedures. Instead, doctors will simply check in with you regularly to see how you're doing and whether the bel-sar treatment (or the sham procedure you may have received) continues to work, what side effects show up over time, and how your overall health and quality of life are affected. The goal is to understand the long-term safety and effectiveness of bel-sar. Researchers want to know: Does the treatment keep working? Do any new side effects appear months or years later? Does the cancer stay controlled, or does it spread? How is your vision? This information will help doctors treat future patients with early eye melanoma better. You'll be asked to fill out questionnaires about how you're feeling and have regular eye exams and check-ups.

What This Trial Does

AU-011-403 is a multicenter long-term follow-up safety and efficacy study of subjects with early CM who previously participated in the AU-011-301 Phase 3 trial. There are no required interventions or use of AU-011 (bel-sar) in this long-term follow-up study

How It Works

Informed consent will be obtained for each subject, preferably during their participation in the AU-011-301 trial and no more than approximately 6 months after their AU-011-301 End of Trial (EoT)/Early Termination (ET) visit. All subjects will be followed for an additional \~5 years (not including AU-011-301 participation). The AU-011-301 assigned subject numbering will continue to be used in this study. The AU-011-301 randomization (treatment received) will continue to be masked during this study until the completion of the AU-011-301 trial and database lock. The purpose of this long-term follow-up study is to learn about how safe and how well bel-sar works over time in people who previously participated in the AU-011-301 study. This will include collecting data from both people who received bel-sar and those who received the sham procedure. The AU-011-403 study will collect data on: Long-term safety will be measured by collecting information about any side effects (adverse events) or serious medical problems (serious adverse events) that may occur. Long-term effectiveness of treatment in AU-011-301 will be measured by looking at any changes in subject's early CM and/or changes in vision over time. Disease progression, including whether the early CM spreads to other parts of the body (metastasis). Survival outcomes, including overall survival and disease-specific survival. Long-term quality of life (QoL) will be measured by using questionnaires (EORTC-QLQ-C30 and EORTC-QLQ-OPT30). This study will help determine how long the effects of bel-sar last and whether any long-term risks or benefits appear after the initial treatment period. The information collected may also help improve treatment options and strategies for future patients with early CM.

Who Can Join

Treatments