Trial · NCT03052127
Study in Subjects With Small Primary Choroidal Melanoma
NCT03052127, Phase 1, Phase 2, Completed, Aura Biosciences; results first posted 2024-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Subjects With Small Primary Choroidal Melanoma. Trials, record NCT03052127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03052127
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Subjects With Small Primary Choroidal Melanoma
- NCT number
- NCT03052127
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Aura Biosciences
- Conditions
- Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
- Interventions
- Light-activated AU-011, Laser Activation
- First posted
- 2017-02-14
- Last updated
- 2024-02-01
- Results first posted
- 2024-02-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Informed consent through 1-2 years | Adverse events will be summarized by presenting the number and percentage of participants having any adverse event. |
| Secondary | Immunogenicity (Anti-AU-011 Antibody Analysis) | Screening to various time points through 24 months | Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA) |
| Secondary | Tumor Size (Thickness) Measured by Ultrasonography [Efficacy] | Change from baseline following treatment and at each subsequent visit through Week 52 | Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound. |
| Secondary | Tumor Size (Diameter) Measured by Fundus Photography [Efficacy] | Change from baseline following treatment and at each subsequent visit through Week 52 | Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011. |
| Secondary | Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye | Change from baseline following treatment and at each subsequent visit through Week 52 | Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Informed consent through 1-2 years | All participants who received at least 1 dose of AU-011 were used for safety analyses.~Adverse events were defined as events that were new or worsened during the treatment period.~AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity (Anti-AU-011 Antibody Analysis) | Screening to various time points through 24 months | Subjects who had at least one post-AU-011 dose result were defined in this study as being evaluable for assessment of treatment-induced antibodies to AU-011.~Negative ADA refers to all negative values at baseline and post-treatment Treatment-induced ADA refers to negative value at baseline and at least 1 positive result post-treatment Treatment-unaffected ADA refers to positive value at baseline and at least 1 reported result post-treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tumor Size (Thickness) Measured by Ultrasonography [Efficacy] | Change from baseline following treatment and at each subsequent visit through Week 52 | The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.~Note: The Baseline tumor thickness (TT) values reported for Cohort 10 in the table below (i.e., 2.583 (0.542)) includes only 2 participants who received AU-011. However, the TT values reported in the Baseline Characteristics table (i.e., 2.6 (0.38) includes 3 participants enrolled in the study (ITT population). | millimeters | MEAN |
| SECONDARY | Tumor Size (Diameter) Measured by Fundus Photography [Efficacy] | Change from baseline following treatment and at each subsequent visit through Week 52 | The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.~Note: The Baseline tumor Largest Basal Diameter (LBD) values reported for Cohort 10 in the table below (i.e., 10.088 (2.825)) includes only 2 participants who received AU-011. However, the LBD values reported in the Baseline Characteristics table (i.e., 9.7 (2.1) includes 3 participants enrolled in Cohort 10 (ITT population). | millimeters | MEAN |
| SECONDARY | Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye | Change from baseline following treatment and at each subsequent visit through Week 52 | The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011. | ETDRS letters | MEAN |
Source ClinicalTrials.gov
Results by group448
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 1 (Light-activated AU-011) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 2 (Single Medium Dose Light-activated AU-011) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 3 (Single High Dose Light-activated AU-011) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 4 (2 Repeat Medium Dose Light-activated AU-011) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 5 (3 Repeat Medium Dose Light-activated AU-011) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 7 (3 Repeat High Dose Light-activated AU-011) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 12 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Cohort 10 (Observation Until Documented Growth of Tumor) | 2 | Participants |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Light-activated AU-011) | 3 | |
| Overall Study | STARTED | Cohort 2 (Single Medium Dose Light-activated AU-011) | 3 | |
| Overall Study | STARTED | Cohort 3 (Single High Dose Light-activated AU-011) | 3 | |
| Overall Study | STARTED | Cohort 4 (2 Repeat Medium Dose Light-activated AU-011) | 3 | |
| Overall Study | STARTED | Cohort 5 (3 Repeat Medium Dose Light-activated AU-011) | 3 | |
| Overall Study | STARTED | Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers) | 3 | |
| Overall Study | STARTED | Cohort 7 (3 Repeat High Dose Light-activated AU-011) | 3 | |
| Overall Study | STARTED | Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 3 | |
| Overall Study | STARTED | Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 12 | |
| Overall Study | STARTED | Cohort 10 (Observation Until Documented Growth of Tumor) | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events480
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anterior chamber cell | Eye disorders | Cohort 1 (Light-activated AU-011) | 1 | 3 | 1 |
| other | Anterior chamber cell | Eye disorders | Cohort 2 (Single Medium Dose Light-activated AU-011) | 1 | 3 | 1 |
| other | Anterior chamber cell | Eye disorders | Cohort 3 (Single High Dose Light-activated AU-011) | 1 | 3 | 2 |
| other | Anterior chamber cell | Eye disorders | Cohort 4 (2 Repeat Medium Dose Light-activated AU-011) | 0 | 3 | 0 |
| other | Anterior chamber cell | Eye disorders | Cohort 5 (3 Repeat Medium Dose Light-activated AU-011) | 0 | 3 | 0 |
| other | Anterior chamber cell | Eye disorders | Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers) | 1 | 3 | 1 |
| other | Anterior chamber cell | Eye disorders | Cohort 7 (3 Repeat High Dose Light-activated AU-011) | 1 | 3 | 2 |
| other | Anterior chamber cell | Eye disorders | Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 0 | 3 | 0 |
| other | Anterior chamber cell | Eye disorders | Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 3 | 12 | 5 |
| other | Anterior chamber cell | Eye disorders | Cohort 10 (Observation Until Documented Growth of Tumor) | 1 | 2 | 1 |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Light-activated AU-011) | 0 | 3 |
| Total, all-cause mortality | Cohort 2 (Single Medium Dose Light-activated AU-011) | 0 | 3 |
| Total, all-cause mortality | Cohort 3 (Single High Dose Light-activated AU-011) | 0 | 3 |
| Total, all-cause mortality | Cohort 4 (2 Repeat Medium Dose Light-activated AU-011) | 0 | 3 |
| Total, all-cause mortality | Cohort 5 (3 Repeat Medium Dose Light-activated AU-011) | 0 | 3 |
| Total, all-cause mortality | Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers) | 0 | 3 |
| Total, all-cause mortality | Cohort 7 (3 Repeat High Dose Light-activated AU-011) | 0 | 3 |
| Total, all-cause mortality | Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 0 | 3 |
| Total, all-cause mortality | Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers) | 0 | 12 |
| Total, all-cause mortality | Cohort 10 (Observation Until Documented Growth of Tumor) | 0 | 2 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03052127
GET https://conductscience.org/api/trials/v1/NCT03052127/results?page=2