Choroidal Melanoma, Indeterminate Lesions
Conditions
Keywords
Ocular Melanoma, Small Choroidal Melanoma
Brief summary
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
Detailed description
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.
Interventions
OTHERObservational
The intention is to collect data for an additional \~5 years (Post AU-011-301 participation)
Sponsors
Aura Biosciences
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301. * Be willing and able to consent to the AU-011-403 study.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs)/serious AEs. | 5 years | The AU-011-403 study is the long-term follow-up study of participants previously treated in AU-011-301.Long-term safety will be assessed by measuring the incidence of adverse events (AEs) and serious adverse events (SAEs) occurring during the follow-up period. AEs will be coded using the same Medical Dictionary for Regulatory Activities version used in AU-011-301 (MedDRA) |
Countries
United States
Contacts
STUDY_DIRECTORMedical Monitor
Aura Biosciences
Outcome results
None listed