Choroidal MelanomaILNCT05266430
Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)
An observational study of Choroidal Melanoma and Indeterminate Lesions, run by Aura Biosciences at 7 sites in United States.
Trial summary
This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma, Indeterminate Lesions
- What is being tested?
- AU-011
- How many people
- 2 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Apr 2022to 20 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with primary Choroidal Melanoma and Indeterminate Lesions who are planned to receive plaque radiotherapy (Control Group) and subjects with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial. (Case Group)
Have per the investigator's expert clinical judgment, a clinical diagnosis of primary indeterminate lesion or choroidal melanoma based on the clinical history, ophthalmic examination, fundus photography and conventional ocular ultrasound.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Retina Consultants of Texas
Bellaire, Texas, 77401
Texas Retina Associates
Dallas, Texas, 75231
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Madison, Wisconsin, 53705
St. Thomas Health/Tennessee Retina, P.C.
Nashville, Tennessee, 37203
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
About this study
Official title: A Prospective Group-Matched Study of Visual Outcomes in Subjects Treated With Belzupacap Sarotalocan (AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)
This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.
Read the detailed description
Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.
- Conditions
- Choroidal Melanoma, Indeterminate Lesions
- Being tested
- Standard of Care, AU-011
- Keywords
- AU-011, Belzupacap sarotalocan, Choroidal melanoma, Plaque radiotherapy, Matched case control, Visual acuity, bel-sar
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator
AU-011Drug
Also called belzupacap sarotalocan, bel-sar
Previously received
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Patients with primary Choroidal Melanoma and Indeterminate Lesions who have received belzupacap sarotalocan (bel-sar; AU-011) in a previous Aura sponsored clinical trial Receives: Drug: AU-011 | |
| Control Group | Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Change from baseline in logMAR visual acuity score at 5 years.
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 posted4 Mar 2022
- Study start14 Apr 2022
- Primary completion1 Feb 2023
- Study completion20 Apr 2023
Why it stopped: Sponsor Decision - Low Enrollment
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-control
- Time perspective
- Prospective
- Enrolment
- 2 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
- NCT05266430
- Sponsor's protocol ID
- AU-011-402
- Acronym
- IL
- Status last verified
- Aug 2023
- First submitted
- 23 Feb 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Group-Matched Study of Visual Outcomes in Subjects Treated With Belzupacap Sarotalocan (AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)
- ClinicalTrials.gov ID
- NCT05266430
- Acronym / sponsor ID
- IL / AU-011-402
- Conditions
- Choroidal Melanoma, Indeterminate Lesions
- Keywords
- AU-011, Belzupacap sarotalocan, Choroidal melanoma, Plaque radiotherapy, Matched case control, Visual acuity, bel-sar
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Decision - Low Enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Aura BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 4 Mar 2022 (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.
This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.
Detailed description
Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Drug: AU-011Patients with primary Choroidal Melanoma and Indeterminate Lesions who have received belzupacap sarotalocan (bel-sar; AU-011) in a previous Aura sponsored clinical trial |
| Control Group | – | Other: Standard of CarePatients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary Choroidal Melanoma and Indeterminate Lesions who are planned to receive plaque radiotherapy (Control Group) and subjects with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial. (Case Group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CarePatients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator | Other | Control Group |
| AU-011Also: belzupacap sarotalocan, bel-sarPreviously received | Drug | Case Group |
Primary outcome
Visual Acuity
Time frame: 5 years
Change from baseline in logMAR visual acuity score at 5 years.
Results and safety
The study was stopped early (reason given: Sponsor Decision - Low Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
7 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, run by Aura Biosciences at 7 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?
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: stopped early, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: Sponsor Decision - Low Enrollment). Results are not available in the source record.
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?
Visual Acuity (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 9 Aug 2023.