Choroidal MelanomaNCT03941379
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
An observational study of Choroidal Melanoma and Indeterminate Lesions of Eye, run by Aura Biosciences at 16 sites in United States.
Trial summary
The purpose of this observational research study is to follow participants who have been treated with bel-sar while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma, Indeterminate Lesions of Eye
- How many people
- 63 participants
- Where
- 16 sitesUnited States
- Study dates
- 27 Mar 2019to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with primary Indeterminate Lesions or Choroidal Melanoma who participated in previous Aura Biosciences sponsored clinical trial.
Who may be able to join
- Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial.
- Have received AU-011 bel-sar treatment in a previous Aura Biosciences sponsored clinical trial.
- Have completed the exit visit of the previous Aura Biosciences sponsored clinical trial within 1 year of Day 1 (≤365 days) of enrollment into the Registry.
Who cannot join
- None
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Texas Retina Associates
Dallas, Texas, 75231
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605
Retina Consultants of Houston
Houston, Texas, 77030
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53705
Retina Center
Minneapolis, Minnesota, 55404
St. Thomas Health / Tennessee Retina, PC
Nashville, Tennessee, 37203
Columbia University Medical Center
New York, New York, 10032
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239
Associated Retinal Consultants, PC
Royal Oak, Michigan, 48073
Retina Consultants of Sacramento
Sacramento, California, 95825
Retina Associates SW, P.C.
Tucson, Arizona, 85710
About this study
The purpose of this observational research study is to follow participants who have been treated with bel-sar while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. The study will collect information based on assessments performed as part of the standard of care (SoC) for subjects with IL/CM, inclusive of all adverse events, concomitant medications and/or procedures, information regarding metastatic disease and details of treatments administered, and information about melanoma-related and all-cause mortality and cause of death (if applicable).
Read the detailed description
This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma.
The Registry is open to subjects who have previously participated in an Aura Biosciences bel-sar sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions.
All subjects will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first.
No interventions will be required as part of the Registry. Data collection will be based on IL or CM information anticipated to be available based on the standard of care for subjects with CM or IL.
- Conditions
- Choroidal Melanoma, Indeterminate Lesions of Eye
- Keywords
- Choroidal Melanoma, Indeterminate Lesions of Eye
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects previously participated in an Aura Biosciences bel-sar study | Subjects with Choroidal Melanoma or Indeterminate Lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start27 Mar 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aura Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Aura Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941379
- Sponsor's protocol ID
- Registry AU-011-401
- Status last verified
- May 2026
- First submitted
- 3 May 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT03941379
- Acronym / sponsor ID
- Registry AU-011-401
- Conditions
- Choroidal Melanoma, Indeterminate Lesions of Eye
- Keywords
- Choroidal Melanoma, Indeterminate Lesions of Eye
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Aura BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational research study is to follow participants who have been treated with bel-sar while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. The study will collect information based on assessments performed as part of the standard of care (SoC) for subjects with IL/CM, inclusive of all adverse events, concomitant medications and/or procedures, information regarding metastatic disease and details of treatments administered, and information about melanoma-related and all-cause mortality and cause of death (if applicable).
Detailed description
This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma.
The Registry is open to subjects who have previously participated in an Aura Biosciences bel-sar sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions.
All subjects will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first.
No interventions will be required as part of the Registry. Data collection will be based on IL or CM information anticipated to be available based on the standard of care for subjects with CM or IL.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects previously participated in an Aura Biosciences bel-sar study | – | –Subjects with Choroidal Melanoma or Indeterminate Lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with primary Indeterminate Lesions or Choroidal Melanoma who participated in previous Aura Biosciences sponsored clinical trial.
Key inclusion criteria (3 listed)
- Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial.
- Have received AU-011 bel-sar treatment in a previous Aura Biosciences sponsored clinical trial.
- Have completed the exit visit of the previous Aura Biosciences sponsored clinical trial within 1 year of Day 1 (≤365 days) of enrollment into the Registry.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Ocular MelanomaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Choroidal Melanoma
Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
Active, not recruitingPhase 3
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
Choroidal Melanoma, Indeterminate Lesions
RecruitingPhase 3
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Uveal Melanoma
Enrolling by invitationObservational study
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Aura Biosciences Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Melanoma and Indeterminate Lesions of Eye, run by Aura Biosciences at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.