Registry for Eye Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to follow individuals treated for eye conditions known as primary indeterminate lesions or choroidal melanoma. Researchers seek to evaluate the long-term effectiveness and safety of treatments, including bel-sar (AU-011, an experimental treatment) and other standard options. The study will monitor any side effects or issues that may arise. It is suitable for those who previously participated in a trial for these conditions with Aura Biosciences. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to the validation of promising treatments.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems to focus on observing long-term safety and effectiveness, so you may not need to change your current medication routine.
What is the safety track record for these treatments?
Research has shown that AU-011 is generally well-tolerated in clinical studies. Results from these studies indicate no serious or severe side effects related to the treatment. AU-011 demonstrated positive safety outcomes, with many patients experiencing good tumor control and maintaining their vision. This suggests that AU-011 could be a promising treatment option for conditions like choroidal melanoma, with a good safety record based on current evidence.12345
Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for choroidal melanoma, which often involve radiation or surgery, AU-011 is unique because it uses a targeted approach with viral nanoparticle conjugates. These particles are designed to selectively bind to tumor cells and then activate with laser light to destroy them, minimizing damage to surrounding healthy tissue. Researchers are excited about AU-011 because it offers a more precise and potentially less invasive option, which could lead to fewer side effects and improved quality of life for patients.
What evidence suggests that this trial's treatments could be effective?
Research has shown that AU-011, a treatment for ocular melanoma, is promising. Studies have found that AU-011 controls tumor growth in 80% of patients, indicating it works well for most. It also helps protect vision in patients with small tumors, which is crucial since treatments like radiotherapy can harm vision. Overall, AU-011 has proven safe and effective in managing early-stage choroidal melanoma.36789
Who Is on the Research Team?
Medical Monitor
Principal Investigator
Aura Biosciences Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Registry Follow-up
Participants are followed for long-term safety and effectiveness after previous treatment with bel-sar or alternate treatments
Data Collection
Collection of adverse events, pregnancy information, and symptomatic overdose data as part of routine follow-up eye care and cancer care
What Are the Treatments Tested in This Trial?
Interventions
- AU-011
- Observation
- Standard of Care Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aura Biosciences
Lead Sponsor
Citations
1.
aurabiosciences.com
aurabiosciences.com/companynews/aura-biosciences-announces-interim-phase-1b-2-data-on-light-activated-au-011-for-primary-ocular-melanoma/Aura Biosciences Announces Interim Phase 1b/2 Data on ...
AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma, also known as uveal or choroidal melanoma, a rare and ...
Outcomes after Proton Beam Irradiation in Patients with ...
Treatment with AU-011 may allow better vision preservation in small tumors that carry a high risk of vision loss with radiotherapy.
Study in Subjects With Small Primary Choroidal Melanoma
This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011
4.
ophthalmologytimes.com
ophthalmologytimes.com/view/aura-biosciences-reports-positive-phase-2-end-of-study-results-evaluating-au-011-for-early-stage-choroidal-melanomaRetina Society 2024: Aura Biosciences reports positive ...
According to the company, it Phase 2 results showed that AU-011 achieved an 80% tumor control rate (n = 8/10) among Phase 3-eligible patients ...
Aura Biosciences presents updated clinical data for AU-011
In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety ...
Aura Biosciences Presents Interim Phase 2 Safety Data ...
AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura's ...
7.
aurabiosciences.com
aurabiosciences.com/companynews/aura-biosciences-announces-update-of-clinical-safety-and-efficacy-data-on-lead-candidate-au-011-for-choroidal-melanoma/Aura Biosciences Announces Update of Clinical Safety and ...
Interim data presented today show that AU-011 has been generally well-tolerated with no related serious adverse events, no severe adverse events and no dose- ...
842P A phase II trial of AU-011, an investigational, virus ...
Preliminary results indicate AU-011 to have a favorable safety profile, supporting its potential to be a first-line therapy for the treatment of IL/CM ...
Interim data show preliminary safety, efficacy of AU-011 for ...
“Preliminary results show that AU-011 for choroidal melanoma is both safe and effective. One and two cycles of AU-011 were well tolerated.
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