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
Public ClinicalTrials.gov record NCT06007690. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
Study identification
- NCT ID
- NCT06007690
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 108 participants
Conditions and interventions
Interventions
- Bel-sar Drug
- Suprachoroidal Microinjector Device
- Infrared Laser Device
- Sham Infrared Laser Device
- Sham Microinjector Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2023 (Actual)
- Primary completion
- Nov 15, 2027 (Estimated)
- Completion
- Aug 15, 2028 (Estimated)
- Last update posted
- Oct 13, 2026
2023 – 2028
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Doris Stein Eye Research Center | Los Angeles | California | 90095 | — |
| Stanford University School of Medicine | Palo Alto | California | 94303 | — |
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95825 | — |
| Emory Eye Center | Atlanta | Georgia | 30322 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| Tufts Medical Center New England Eye Center | Boston | Massachusetts | 02111 | — |
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | — |
| W.K. Kellogg Eye Center - University of Michigan | Ann Arbor | Michigan | 48105 | — |
| Associated Retinal Consultants (ARC) P.C. | Royal Oak | Michigan | 48073 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Cole Eye Institute | Cleveland | Ohio | 44195 | — |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | — |
| Retina Consultants of Oklahoma | Oklahoma City | Oklahoma | 73112 | — |
| Shields & Shields PC-Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | — |
| Retina Consultants of Carolina | Greenville | South Carolina | 29605 | — |
| Tennessee Retina, PC | Nashville | Tennessee | 37203 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Texas Retina Associates | Dallas | Texas | 75231 | — |
| Eye Cancer Associates of Texas | Houston | Texas | 77057 | — |
| Retina Center of Texas | Southlake | Texas | 76092 | — |
| Retina Associates of Utah | Salt Lake City | Utah | 84107 | — |
| Vitreoretinal Associates of Washington | Bellevue | Washington | 98004 | — |
| University of Washington Medical Center | Seattle | Washington | 98104 | — |
| University of Wisconsin Madison | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06007690, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06007690 live on ClinicalTrials.gov.