Study in Subjects With Small Primary Choroidal Melanoma

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 for the Treatment of Subjects With Small Primary Choroidal Melanoma

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03052127

Enrollment

Registered

2017-02-14

Start date

2017-02-27

Completion date

2021-01-26

Last updated

2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Melanoma, Ocular Melanoma, Uveal Melanoma

Keywords

Uveal melanoma, Eye cancer, Ocular melanoma, Choroidal melanoma

Brief summary

The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.

Detailed description

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 for the treatment of subjects with small primary choroidal melanoma. Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.

Interventions

DRUGLight-activated AU-011

Study treatment

DEVICELaser Activation

Study treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of choroidal melanoma

Exclusion criteria

* Have known contraindications or sensitivities to the study drug

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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.
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.
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.

Countries

United States

Participant flow

Recruitment details

A total of 57 participants with Primary Choroidal Melanoma at 15 sites in the USA were enrolled and 56 were treated with at least 1 dose of AU-011 at 3 dose levels and repeat dose regimens in 1 or 2 treatment cycles with 1 or 2 laser applications.

Pre-assignment details

This open-label, multicenter, dose escalation trial with expansion cohorts was designed to evaluate the safety, immunogenicity, and efficacy of up to 2 treatment cycles of intravitreal (IVT) AU-011 aimed to enroll approximately 60 participants with small primary CM. The tables were created for overall and by cohort as part of the study design. Each study participant contributed only 1 eye (study eye).

Participants by arm

Arm	Count
Cohort 1 (Light-activated AU-011) Low dose (20 µg) Light-activated AU-011 followed by a single laser light application Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 2 (Single Medium Dose Light-activated AU-011) Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 3 (Single High Dose Light-activated AU-011) High dose (80 µg) Light-activated AU-011 followed by a single laser light application Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011) 2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011) 3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers) High dose (80 µg) Light-activated AU-011 followed by two laser light applications Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 7 (3 Repeat High Dose Light-activated AU-011) 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers) 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers) Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment Light-activated AU-011: Study treatment Laser Activation: Study treatment	12
Cohort 10 (Observation Until Documented Growth of Tumor) Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications Light-activated AU-011: Study treatment Laser Activation: Study treatment	3
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers) Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications Light-activated AU-011: Study treatment Laser Activation: Study treatment	5
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers) Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry Light-activated AU-011: Study treatment Laser Activation: Study treatment	13
Total	57

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011
Overall Study	COVID-19 restrictions and Investigator discretion	1	0	1	1	1	0	0	0	0	0
Overall Study	Discontinuation by Sponsor	0	0	0	0	0	0	4	2	5	13
Overall Study	Inability to comply with trial requirements	0	1	0	0	0	0	0	0	0	0
Overall Study	Withdrawal by Subject	0	0	0	0	0	1	1	1	0	0

Baseline characteristics

Characteristic	Cohort 2 (Single Medium Dose Light-activated AU-011)	Total	Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Cohort 10 (Observation Until Documented Growth of Tumor)	Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Cohort 3 (Single High Dose Light-activated AU-011)	Cohort 1 (Light-activated AU-011)
Age, Continuous	61.3 Years STANDARD_DEVIATION 10.02	55.7 Years STANDARD_DEVIATION 12.89	49.5 Years STANDARD_DEVIATION 17.85	68.8 Years STANDARD_DEVIATION 4.66	58.0 Years STANDARD_DEVIATION 9.64	57.1 Years STANDARD_DEVIATION 10.47	57.0 Years STANDARD_DEVIATION 13	48.0 Years STANDARD_DEVIATION 14.93	56.0 Years STANDARD_DEVIATION 13.11	52.0 Years STANDARD_DEVIATION 11.53	50.3 Years STANDARD_DEVIATION 9.07	65.3 Years STANDARD_DEVIATION 5.13	52.7 Years STANDARD_DEVIATION 6.51
Baseline Risk factors Documented Growth	2 Participants	35 Participants	13 Participants	5 Participants	0 Participants	7 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	3 Participants
Baseline Risk factors Flashes or floaters	2 Participants	27 Participants	5 Participants	3 Participants	2 Participants	3 Participants	3 Participants	3 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Baseline Risk factors Orange pigmentation	3 Participants	46 Participants	8 Participants	5 Participants	2 Participants	10 Participants	3 Participants	2 Participants	3 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Baseline Risk factors Subretinal fluid	3 Participants	54 Participants	11 Participants	5 Participants	3 Participants	12 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	2 Participants
Baseline Risk factors Vision loss	0 Participants	12 Participants	6 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Baseline Tumor Characteristics Distance from fovea	3.8 millimeters STANDARD_DEVIATION 2.4	3.2 millimeters STANDARD_DEVIATION 2.7	0.9 millimeters STANDARD_DEVIATION 0.7	3.6 millimeters STANDARD_DEVIATION 4.4	3.9 millimeters STANDARD_DEVIATION 3.7	2.9 millimeters STANDARD_DEVIATION 2	6.1 millimeters STANDARD_DEVIATION 2.9	5.0 millimeters STANDARD_DEVIATION 5	3.8 millimeters STANDARD_DEVIATION 1.8	1.8 millimeters STANDARD_DEVIATION 2.1	4.9 millimeters STANDARD_DEVIATION 3.3	4.6 millimeters STANDARD_DEVIATION 0.95	4.8 millimeters STANDARD_DEVIATION 0.71
Baseline Tumor Characteristics Distance from nerve edge	2.1 millimeters STANDARD_DEVIATION 2.7	3.6 millimeters STANDARD_DEVIATION 3	2.9 millimeters STANDARD_DEVIATION 1.5	3.8 millimeters STANDARD_DEVIATION 3.6	3.0 millimeters STANDARD_DEVIATION 1.8	2.6 millimeters STANDARD_DEVIATION 2.2	4.5 millimeters STANDARD_DEVIATION 7.6	4.0 millimeters STANDARD_DEVIATION 5.1	6.5 millimeters STANDARD_DEVIATION 1.4	1.7 millimeters STANDARD_DEVIATION 1.5	2.2 millimeters STANDARD_DEVIATION 3.3	6.5 millimeters STANDARD_DEVIATION 2.7	7.7 millimeters STANDARD_DEVIATION 1.4
Baseline Tumor Characteristics Tumor largest basal diameter	8.4 millimeters STANDARD_DEVIATION 1.4	8.6 millimeters STANDARD_DEVIATION 2.1	7.9 millimeters STANDARD_DEVIATION 1.5	7.5 millimeters STANDARD_DEVIATION 1.1	9.7 millimeters STANDARD_DEVIATION 2.1	9.5 millimeters STANDARD_DEVIATION 2.7	12.3 millimeters STANDARD_DEVIATION 1.5	7.9 millimeters STANDARD_DEVIATION 1	7.5 millimeters STANDARD_DEVIATION 1.2	8.9 millimeters STANDARD_DEVIATION 2.2	7.8 millimeters STANDARD_DEVIATION 1.7	7.7 millimeters STANDARD_DEVIATION 1.4	7.7 millimeters STANDARD_DEVIATION 2.2
Baseline Tumor Characteristics Tumor lesion thickness	2.7 millimeters STANDARD_DEVIATION 0.73	2.1 millimeters STANDARD_DEVIATION 0.52	1.8 millimeters STANDARD_DEVIATION 0.6	1.9 millimeters STANDARD_DEVIATION 0.38	2.6 millimeters STANDARD_DEVIATION 0.38	2.1 millimeters STANDARD_DEVIATION 0.42	2.9 millimeters STANDARD_DEVIATION 0.32	2.2 millimeters STANDARD_DEVIATION 0.54	2.2 millimeters STANDARD_DEVIATION 0.15	2.2 millimeters STANDARD_DEVIATION 0.23	2.0 millimeters STANDARD_DEVIATION 0.26	2.4 millimeters STANDARD_DEVIATION 0.35	1.9 millimeters STANDARD_DEVIATION 0.58
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants	55 Participants	13 Participants	5 Participants	3 Participants	12 Participants	2 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	3 Participants	56 Participants	13 Participants	5 Participants	3 Participants	12 Participants	3 Participants	3 Participants	3 Participants	3 Participants	2 Participants	3 Participants	3 Participants
Region of Enrollment United States	3 participants	57 participants	13 participants	5 participants	3 participants	12 participants	3 participants	3 participants	3 participants	3 participants	3 participants	3 participants	3 participants
Sex: Female, Male Female	2 Participants	25 Participants	6 Participants	3 Participants	1 Participants	6 Participants	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Sex: Female, Male Male	1 Participants	32 Participants	7 Participants	2 Participants	2 Participants	6 Participants	2 Participants	3 Participants	1 Participants	2 Participants	1 Participants	2 Participants	3 Participants
Visual Acuity Scores (ETDRS Letters) in Both Eyes Fellow Eye	72.7 letters on ETDRS scale STANDARD_DEVIATION 17.62	85.7 letters on ETDRS scale STANDARD_DEVIATION 9.57	85.1 letters on ETDRS scale STANDARD_DEVIATION 9.02	86.2 letters on ETDRS scale STANDARD_DEVIATION 7.16	91.0 letters on ETDRS scale STANDARD_DEVIATION 4.58	88.6 letters on ETDRS scale STANDARD_DEVIATION 7.08	75.0 letters on ETDRS scale STANDARD_DEVIATION 19.97	89.0 letters on ETDRS scale STANDARD_DEVIATION 2.65	86.0 letters on ETDRS scale STANDARD_DEVIATION 7.21	90.3 letters on ETDRS scale STANDARD_DEVIATION 1.53	91.7 letters on ETDRS scale STANDARD_DEVIATION 4.73	80.0 letters on ETDRS scale STANDARD_DEVIATION 13.86	86.3 letters on ETDRS scale STANDARD_DEVIATION 4.62
Visual Acuity Scores (ETDRS Letters) in Both Eyes Study Eye	81.0 letters on ETDRS scale STANDARD_DEVIATION 14.18	82.6 letters on ETDRS scale STANDARD_DEVIATION 9.83	77.9 letters on ETDRS scale STANDARD_DEVIATION 11.83	81.2 letters on ETDRS scale STANDARD_DEVIATION 6.34	86.0 letters on ETDRS scale STANDARD_DEVIATION 12.7	82.9 letters on ETDRS scale STANDARD_DEVIATION 10.13	82.7 letters on ETDRS scale STANDARD_DEVIATION 3.21	87.3 letters on ETDRS scale STANDARD_DEVIATION 5.13	87.0 letters on ETDRS scale STANDARD_DEVIATION 3.61	75.7 letters on ETDRS scale STANDARD_DEVIATION 10.69	88.3 letters on ETDRS scale STANDARD_DEVIATION 14.36	87.3 letters on ETDRS scale STANDARD_DEVIATION 4.93	89.7 letters on ETDRS scale STANDARD_DEVIATION 0.58

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 12	0 / 2	0 / 5	0 / 13
other Total, other adverse events	3 / 3	3 / 3	3 / 3	3 / 3	3 / 3	3 / 3	3 / 3	3 / 3	12 / 12	2 / 2	5 / 5	13 / 13
serious Total, serious adverse events	0 / 3	0 / 3	1 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 12	0 / 2	2 / 5	1 / 13

Outcome results

Primary

Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011

Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.

Time frame: Informed consent through 1-2 years

Population: 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 \[v4.03\]).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 (Light-activated AU-011)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 2 (Single Medium Dose Light-activated AU-011)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 3 (Single High Dose Light-activated AU-011)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3 Participants
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	12 Participants
Cohort 10 (Observation Until Documented Growth of Tumor)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	2 Participants
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	5 Participants
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	13 Participants

Secondary

Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye

Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.

Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

Population: The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-6.3 ETDRS letters	Standard Deviation 2.08
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	0.3 ETDRS letters	Standard Deviation 3.06
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-3.0 ETDRS letters	Standard Deviation 2.83
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-26.0 ETDRS letters	—
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-4.3 ETDRS letters	Standard Deviation 5.86
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-4.0 ETDRS letters	Standard Deviation 5.66
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-5.3 ETDRS letters	Standard Deviation 4.04
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	89.7 ETDRS letters	Standard Deviation 0.58
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	-2.3 ETDRS letters	Standard Deviation 2.52
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-2.3 ETDRS letters	Standard Deviation 3.79
Cohort 1 (Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-2.0 ETDRS letters	Standard Deviation 2.65
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	5.3 ETDRS letters	Standard Deviation 3.21
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-18.7 ETDRS letters	Standard Deviation 34.93
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-11.0 ETDRS letters	Standard Deviation 20.78
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	0.3 ETDRS letters	Standard Deviation 3.79
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	0.3 ETDRS letters	Standard Deviation 2.08
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	81.0 ETDRS letters	Standard Deviation 14.18
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	4.0 ETDRS letters	Standard Deviation 3.61
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-0.3 ETDRS letters	Standard Deviation 4.73
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-4.0 ETDRS letters	Standard Deviation 12.17
Cohort 2 (Single Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	4.0 ETDRS letters	Standard Deviation 1
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	-3.3 ETDRS letters	Standard Deviation 4.93
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	87.3 ETDRS letters	Standard Deviation 4.93
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-7.0 ETDRS letters	Standard Deviation 8.19
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-9.7 ETDRS letters	Standard Deviation 8.33
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-2.3 ETDRS letters	Standard Deviation 4.51
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-7.3 ETDRS letters	Standard Deviation 6.03
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-3.0 ETDRS letters	Standard Deviation 3
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-3.0 ETDRS letters	Standard Deviation 2.65
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	0.5 ETDRS letters	Standard Deviation 0.71
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	1.5 ETDRS letters	Standard Deviation 2.12
Cohort 3 (Single High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-14.3 ETDRS letters	Standard Deviation 17.04
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-13.7 ETDRS letters	Standard Deviation 7.23
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	-1.3 ETDRS letters	Standard Deviation 2.08
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-4.0 ETDRS letters	Standard Deviation 1.73
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-9.0 ETDRS letters	Standard Deviation 7.55
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	-3.0 ETDRS letters	Standard Deviation 6.56
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	88.3 ETDRS letters	Standard Deviation 14.36
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-11.7 ETDRS letters	Standard Deviation 4.73
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-4.7 ETDRS letters	Standard Deviation 9.07
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-5.3 ETDRS letters	Standard Deviation 4.93
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-11.3 ETDRS letters	Standard Deviation 4.73
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-2.7 ETDRS letters	Standard Deviation 1.53
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-6.0 ETDRS letters	Standard Deviation 7.94
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-13.0 ETDRS letters	Standard Deviation 7
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	-9.0 ETDRS letters	Standard Deviation 2.83
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-14.7 ETDRS letters	Standard Deviation 14.57
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-9.3 ETDRS letters	Standard Deviation 1.15
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-12.0 ETDRS letters	Standard Deviation 13.23
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	-4.3 ETDRS letters	Standard Deviation 4.62
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 16 (Visit 7)	-15.7 ETDRS letters	Standard Deviation 10.26
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-1.7 ETDRS letters	Standard Deviation 16.01
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-7.0 ETDRS letters	Standard Deviation 23.07
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-1.0 ETDRS letters	Standard Deviation 1.41
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	75.7 ETDRS letters	Standard Deviation 10.69
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-7.7 ETDRS letters	Standard Deviation 22.01
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-10.0 ETDRS letters	Standard Deviation 7.55
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-9.7 ETDRS letters	Standard Deviation 20.31
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-11.0 ETDRS letters	Standard Deviation 12.12
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-9.0 ETDRS letters	Standard Deviation 15.52
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-10.7 ETDRS letters	Standard Deviation 22.85
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	87.0 ETDRS letters	Standard Deviation 3.61
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-11.7 ETDRS letters	Standard Deviation 21.36
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-11.0 ETDRS letters	Standard Deviation 21.63
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-11.3 ETDRS letters	Standard Deviation 21.39
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	-6.3 ETDRS letters	Standard Deviation 8.39
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-11.0 ETDRS letters	Standard Deviation 6.56
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-13.3 ETDRS letters	Standard Deviation 17.95
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	0.3 ETDRS letters	Standard Deviation 4.16
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	0 ETDRS letters	Standard Deviation 8
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-2.0 ETDRS letters	Standard Deviation 6.56
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 16 (Visit 7)	-1.3 ETDRS letters	Standard Deviation 11.68
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	87.3 ETDRS letters	Standard Deviation 5.13
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-13.7 ETDRS letters	Standard Deviation 23.46
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-36.0 ETDRS letters	Standard Deviation 38.18
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	2.0 ETDRS letters	Standard Deviation 2
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-2.0 ETDRS letters	Standard Deviation 2.65
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-5.3 ETDRS letters	Standard Deviation 9.5
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-8.3 ETDRS letters	Standard Deviation 13.65
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-1.3 ETDRS letters	Standard Deviation 4.04
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	3.3 ETDRS letters	Standard Deviation 2.52
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-0.7 ETDRS letters	Standard Deviation 4.51
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	-13.0 ETDRS letters	Standard Deviation 23.4
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	-30.0 ETDRS letters	Standard Deviation 47.76
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-4.7 ETDRS letters	Standard Deviation 8.96
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-1.0 ETDRS letters	Standard Deviation 6.08
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	82.7 ETDRS letters	Standard Deviation 3.21
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-0.7 ETDRS letters	Standard Deviation 3.06
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-15.0 ETDRS letters	Standard Deviation 16.52
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 16 (Visit 7)	-17.3 ETDRS letters	Standard Deviation 12.06
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-5.3 ETDRS letters	Standard Deviation 2.08
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-1.0 ETDRS letters	Standard Deviation 0
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-10.0 ETDRS letters	Standard Deviation 10.15
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-10.0 ETDRS letters	Standard Deviation 9.54
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-3.8 ETDRS letters	Standard Deviation 4.39
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 16 (Visit 7)	-17.0 ETDRS letters	Standard Deviation 16.15
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-26.0 ETDRS letters	Standard Deviation 29.6
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-8.7 ETDRS letters	Standard Deviation 7.4
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-6.6 ETDRS letters	Standard Deviation 8.2
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	82.9 ETDRS letters	Standard Deviation 10.13
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-1.5 ETDRS letters	Standard Deviation 4.36
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-8.7 ETDRS letters	Standard Deviation 25.43
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-15.7 ETDRS letters	Standard Deviation 26.56
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-4.1 ETDRS letters	Standard Deviation 9.49
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	0.1 ETDRS letters	Standard Deviation 3.32
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	-3.4 ETDRS letters	Standard Deviation 8.16
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-4.0 ETDRS letters	Standard Deviation 6.97
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	-0.5 ETDRS letters	Standard Deviation 4.95
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-27.5 ETDRS letters	Standard Deviation 7.78
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	0 ETDRS letters	Standard Deviation 4.24
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 16 (Visit 7)	0 ETDRS letters	Standard Deviation 2.83
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	0 ETDRS letters	Standard Deviation 3
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-25.0 ETDRS letters	Standard Deviation 11.31
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	86.0 ETDRS letters	Standard Deviation 12.77
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-4.0 ETDRS letters	Standard Deviation 7.07
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	0.5 ETDRS letters	Standard Deviation 3.54
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-14.0 ETDRS letters	Standard Deviation 5.66
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-13.5 ETDRS letters	Standard Deviation 17.68
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-6.5 ETDRS letters	Standard Deviation 12.02
Cohort 10 (Observation Until Documented Growth of Tumor)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	3.5 ETDRS letters	Standard Deviation 2.12
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	-8.2 ETDRS letters	Standard Deviation 12.5
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-13.0 ETDRS letters	Standard Deviation 18.64
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-14.2 ETDRS letters	Standard Deviation 23.12
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-10.2 ETDRS letters	Standard Deviation 16.63
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 16 (Visit 7)	-28.0 ETDRS letters	Standard Deviation 28.02
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-20.6 ETDRS letters	Standard Deviation 31.71
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-16.8 ETDRS letters	Standard Deviation 19.27
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-26.0 ETDRS letters	Standard Deviation 25.81
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	81.2 ETDRS letters	Standard Deviation 6.34
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-14.2 ETDRS letters	Standard Deviation 21.32
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-18.6 ETDRS letters	Standard Deviation 23.39
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-17.2 ETDRS letters	Standard Deviation 20.91
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	0.4 ETDRS letters	Standard Deviation 3.36
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 8 (Visit 4)	1.6 ETDRS letters	Standard Deviation 4.29
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 26 (Visit 12)	-9.8 ETDRS letters	Standard Deviation 13.57
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 2 (Visit 3)	-0.5 ETDRS letters	Standard Deviation 4.67
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 12 (Visit 11)	-9.4 ETDRS letters	Standard Deviation 15.17
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 8 (Visit 10)	-8.7 ETDRS letters	Standard Deviation 16.18
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 39 (Visit 13)	-10.6 ETDRS letters	Standard Deviation 15.14
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 6 (Visit 9)	-7.5 ETDRS letters	Standard Deviation 16.1
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 29 (Visit 8)	-12.0 ETDRS letters	Standard Deviation 16.38
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 9 (Visit 5)	-6.2 ETDRS letters	Standard Deviation 13.01
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 16 (Visit 7)	-8.8 ETDRS letters	Standard Deviation 15.24
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Day 15 (Visit 6)	-7.1 ETDRS letters	Standard Deviation 16.32
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Baseline	77.9 ETDRS letters	Standard Deviation 11.83
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Week 52 (Visit 14)	-16.1 ETDRS letters	Standard Deviation 18.34

Secondary

Immunogenicity (Anti-AU-011 Antibody Analysis)

Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)

Time frame: Screening to various time points through 24 months

Population: 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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 (Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 1 (Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	2 Participants
Cohort 1 (Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	1 Participants
Cohort 2 (Single Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 2 (Single Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	2 Participants
Cohort 2 (Single Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	1 Participants
Cohort 3 (Single High Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 3 (Single High Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	0 Participants
Cohort 3 (Single High Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	3 Participants
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	1 Participants
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	1 Participants
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	1 Participants
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	0 Participants
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	2 Participants
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	1 Participants
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	2 Participants
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	1 Participants
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	1 Participants
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	2 Participants
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	3 Participants
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	0 Participants
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	8 Participants
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	4 Participants
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 10 (Observation Until Documented Growth of Tumor)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 10 (Observation Until Documented Growth of Tumor)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	1 Participants
Cohort 10 (Observation Until Documented Growth of Tumor)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	1 Participants
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	0 Participants
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	0 Participants
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	5 Participants
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-unaffected ADA	1 Participants
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Negative ADA	1 Participants
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Immunogenicity (Anti-AU-011 Antibody Analysis)	Treatment-induced ADA	11 Participants

Secondary

Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]

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.

Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

Population: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	-0.165 millimeters	Standard Deviation 0.184
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	-0.472 millimeters	Standard Deviation 0.774
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.070 millimeters	Standard Deviation 0.332
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	7.740 millimeters	Standard Deviation 2.197
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.085 millimeters	Standard Deviation 0.212
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.070 millimeters	Standard Deviation 0.198
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	0.230 millimeters	Standard Deviation 0.453
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.060 millimeters	Standard Deviation 0.007
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.203 millimeters	Standard Deviation 0.414
Cohort 1 (Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	-0.468 millimeters	Standard Deviation 0.842
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	-0.035 millimeters	Standard Deviation 0.347
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	8.350 millimeters	Standard Deviation 1.4
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	0.827 millimeters	Standard Deviation 0.725
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.805 millimeters	Standard Deviation 0.781
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.273 millimeters	Standard Deviation 0.475
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.147 millimeters	Standard Deviation 0.14
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.280 millimeters	Standard Deviation 0.156
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	-0.032 millimeters	Standard Deviation 0.618
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.003 millimeters	Standard Deviation 0.339
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.347 millimeters	Standard Deviation 0.289
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.545 millimeters	Standard Deviation 0.332
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.288 millimeters	Standard Deviation 0.239
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.657 millimeters	Standard Deviation 0.144
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	7.700 millimeters	Standard Deviation 1.375
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.625 millimeters	Standard Deviation 0.435
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	0.427 millimeters	Standard Deviation 0.18
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.225 millimeters	Standard Deviation 0.628
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.023 millimeters	Standard Deviation 0.253
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.730 millimeters	Standard Deviation 0.265
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.417 millimeters	Standard Deviation 0.212
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.413 millimeters	Standard Deviation 0.35
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	0.473 millimeters	Standard Deviation 0.464
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	7.815 millimeters	Standard Deviation 1.681
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.740 millimeters	Standard Deviation 0.014
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.092 millimeters	Standard Deviation 0.226
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.998 millimeters	Standard Deviation 0.959
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.383 millimeters	Standard Deviation 0.16
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.963 millimeters	Standard Deviation 0.752
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.807 millimeters	Standard Deviation 0.478
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.580 millimeters	Standard Deviation 0.18
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.627 millimeters	Standard Deviation 0.477
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.225 millimeters	Standard Deviation 0.065
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	1.605 millimeters	Standard Deviation 1.286
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.015 millimeters	Standard Deviation 0.566
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.412 millimeters	Standard Deviation 1.086
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	0.853 millimeters	Standard Deviation 1.199
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.072 millimeters	Standard Deviation 0.362
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.087 millimeters	Standard Deviation 0.253
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	-0.308 millimeters	Standard Deviation 0.103
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.445 millimeters	Standard Deviation 0.507
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	8.853 millimeters	Standard Deviation 2.146
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.103 millimeters	Standard Deviation 0.45
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.168 millimeters	Standard Deviation 0.339
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 16 (Visit 7)	-0.010 millimeters	Standard Deviation 0.426
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.198 millimeters	Standard Deviation 0.61
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	-0.007 millimeters	Standard Deviation 0.363
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.080 millimeters	Standard Deviation 0.339
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	0.937 millimeters	Standard Deviation 0.814
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	7.492 millimeters	Standard Deviation 1.227
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.063 millimeters	Standard Deviation 0.201
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.500 millimeters	Standard Deviation 0.12
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.115 millimeters	Standard Deviation 0.05
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.285 millimeters	Standard Deviation 0.021
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.122 millimeters	Standard Deviation 0.214
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.497 millimeters	Standard Deviation 0.138
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.695 millimeters	Standard Deviation 0.785
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.730 millimeters	Standard Deviation 0.692
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.930 millimeters	Standard Deviation 0.552
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	2.993 millimeters	Standard Deviation 1.095
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	2.70 millimeters	Standard Deviation 0.961
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.343 millimeters	Standard Deviation 0.06
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 16 (Visit 7)	0.317 millimeters	Standard Deviation 0.025
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	7.927 millimeters	Standard Deviation 1.03
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.333 millimeters	Standard Deviation 0.032
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	0.265 millimeters	Standard Deviation 0.141
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	2.552 millimeters	Standard Deviation 1.552
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.970 millimeters	Standard Deviation 0.599
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.083 millimeters	Standard Deviation 0.131
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.105 millimeters	Standard Deviation 0.102
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.285 millimeters	Standard Deviation 0.069
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	2.635 millimeters	—
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	1.013 millimeters	Standard Deviation 0.067
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.895 millimeters	—
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.340 millimeters	Standard Deviation 0.149
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	2.56 millimeters	—
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.410 millimeters	—
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	0.918 millimeters	Standard Deviation 0.378
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.730 millimeters	Standard Deviation 0.644
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	1.660 millimeters	—
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	1.853 millimeters	Standard Deviation 0.661
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 16 (Visit 7)	1.120 millimeters	Standard Deviation 1.004
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	2.857 millimeters	Standard Deviation 1.425
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	12.257 millimeters	Standard Deviation 1.533
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	1.381 millimeters	Standard Deviation 1.223
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 16 (Visit 7)	-0.049 millimeters	Standard Deviation 0.899
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.626 millimeters	Standard Deviation 0.918
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	1.342 millimeters	Standard Deviation 1.2
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	-0.175 millimeters	Standard Deviation 0.482
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	-0.154 millimeters	Standard Deviation 0.552
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	9.533 millimeters	Standard Deviation 2.688
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	1.774 millimeters	Standard Deviation 1.254
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.534 millimeters	Standard Deviation 1.173
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	-0.161 millimeters	Standard Deviation 0.496
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.981 millimeters	Standard Deviation 1.641
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.019 millimeters	Standard Deviation 0.498
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	-0.130 millimeters	Standard Deviation 0.579
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	10.088 millimeters	Standard Deviation 2.825
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.250 millimeters	—
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	-0.010 millimeters	Standard Deviation 0.481
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	-0.395 millimeters	—
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.67 millimeters	Standard Deviation 0.414
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	1.630 millimeters	—
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	-0.115 millimeters	Standard Deviation 0.064
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	0.285 millimeters	—
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.065 millimeters	Standard Deviation 0.481
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.490 millimeters	Standard Deviation 0.212
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 16 (Visit 7)	0.245 millimeters	—
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	1.197 millimeters	Standard Deviation 0.919
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.503 millimeters	Standard Deviation 0.236
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.033 millimeters	Standard Deviation 0.287
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	7.502 millimeters	Standard Deviation 1.058
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.083 millimeters	Standard Deviation 0.215
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	-0.222 millimeters	Standard Deviation 0.251
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	-0.073 millimeters	Standard Deviation 0.129
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	0.977 millimeters	Standard Deviation 0.365
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	0.060 millimeters	Standard Deviation 0.048
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.738 millimeters	Standard Deviation 0.499
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 16 (Visit 7)	0.037 millimeters	Standard Deviation 0.928
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	-0.021 millimeters	Standard Deviation 0.086
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.223 millimeters	Standard Deviation 0.335
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 12 (Visit 11)	0.657 millimeters	Standard Deviation 0.703
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 15 (Visit 6)	0.175 millimeters	Standard Deviation 0.319
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 8 (Visit 10)	0.314 millimeters	Standard Deviation 0.406
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 26 (Visit 12)	0.666 millimeters	Standard Deviation 0.803
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 39 (Visit 13)	1.224 millimeters	Standard Deviation 0.952
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Baseline	7.869 millimeters	Standard Deviation 1.532
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 29 (Visit 8)	0.199 millimeters	Standard Deviation 0.549
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 16 (Visit 7)	0.265 millimeters	Standard Deviation 0.342
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 9 (Visit 5)	0.066 millimeters	Standard Deviation 0.197
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 52 (Visit 14)	1.457 millimeters	Standard Deviation 1.456
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 8 (Visit 4)	0.168 millimeters	Standard Deviation 0.329
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Week 6 (Visit 9)	0.293 millimeters	Standard Deviation 0.369
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Day 2 (Visit 3)	-0.012 millimeters	Standard Deviation 0.234

Secondary

Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]

Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.

Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

Population: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.033 millimeters	Standard Deviation 0.233
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	-0.042 millimeters	Standard Deviation 0.012
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	-0.061 millimeters	Standard Deviation 0.151
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	-0.006 millimeters	Standard Deviation 0.177
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	-0.067 millimeters	Standard Deviation 0.047
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	-0.017 millimeters	Standard Deviation 0.024
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	1.872 millimeters	Standard Deviation 0.576
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	-0.117 millimeters	Standard Deviation 0.118
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	-0.067 millimeters	Standard Deviation 0.094
Cohort 1 (Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 2 (Visit 3)	-0.56 millimeters	Standard Deviation 0.069
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	1.067 millimeters	Standard Deviation 1.393
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	0.022 millimeters	Standard Deviation 0.084
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.678 millimeters	Standard Deviation 0.734
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.333 millimeters	Standard Deviation 0.285
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	0.978 millimeters	Standard Deviation 0.956
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 2 (Visit 3)	0 millimeters	Standard Deviation 0.1
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.044 millimeters	Standard Deviation 0.135
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.267 millimeters	Standard Deviation 0.2
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.056 millimeters	Standard Deviation 0.158
Cohort 2 (Single Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.189 millimeters	Standard Deviation 1.151
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	-0.067 millimeters	Standard Deviation 0.094
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.144 millimeters	Standard Deviation 0.252
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.389 millimeters	Standard Deviation 0.347
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.111 millimeters	Standard Deviation 0.337
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.067 millimeters	Standard Deviation 0.24
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	0.267 millimeters	Standard Deviation 0.635
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	-0.067 millimeters	Standard Deviation 0.047
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 2 (Visit 3)	-0.011 millimeters	Standard Deviation 0.038
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	0.044 millimeters	Standard Deviation 0.084
Cohort 3 (Single High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.033 millimeters	Standard Deviation 0.133
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	-0.156 millimeters	Standard Deviation 0.269
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.033 millimeters	Standard Deviation 0.265
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	-0.300 millimeters	Standard Deviation 0.449
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 2 (Visit 3)	-0.033 millimeters	Standard Deviation 0
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	0.044 millimeters	Standard Deviation 0.039
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.044 millimeters	Standard Deviation 0.019
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	-0.333 millimeters	Standard Deviation 0.384
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	-0.044 millimeters	Standard Deviation 0.184
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	-0.111 millimeters	Standard Deviation 0.204
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	-0.044 millimeters	Standard Deviation 0.154
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	0.322 millimeters	Standard Deviation 0.32
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.022 millimeters	Standard Deviation 0.077
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.011 millimeters	Standard Deviation 0.126
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	0.211 millimeters	Standard Deviation 0.278
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.078 millimeters	Standard Deviation 0.039
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.233 millimeters	Standard Deviation 0.233
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.033 millimeters	Standard Deviation 0.067
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	-0.011 millimeters	Standard Deviation 0.039
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.500 millimeters	Standard Deviation 0.404
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0 millimeters	Standard Deviation 0.047
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.033 millimeters	Standard Deviation 0.12
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	-0.050 millimeters	Standard Deviation 0.071
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.156 millimeters	Standard Deviation 0.356
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	0.078 millimeters	Standard Deviation 0.25
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.233 millimeters	Standard Deviation 0.153
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	-0.100 millimeters	Standard Deviation 0.12
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.056 millimeters	Standard Deviation 0.126
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	0.044 millimeters	Standard Deviation 0.217
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	0.067 millimeters	Standard Deviation 0.033
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.433 millimeters	Standard Deviation 0.404
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.333 millimeters	Standard Deviation 0.208
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.21 millimeters	Standard Deviation 0.184
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	0.733 millimeters	Standard Deviation 0.569
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.044 millimeters	Standard Deviation 0.084
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.078 millimeters	Standard Deviation 0.164
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.167 millimeters	Standard Deviation 0.536
Cohort 7 (3 Repeat High Dose Light-activated AU-011)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	0.133 millimeters	—
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.078 millimeters	Standard Deviation 0.051
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.111 millimeters	Standard Deviation 0.138
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.889 millimeters	Standard Deviation 0.32
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	-0.044 millimeters	Standard Deviation 0.077
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.122 millimeters	Standard Deviation 0.126
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.233 millimeters	Standard Deviation 0.219
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	0.667 millimeters	Standard Deviation 0.839
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	0.300 millimeters	Standard Deviation 0.141
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.456 millimeters	Standard Deviation 0.32
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	-0.012 millimeters	Standard Deviation 0.111
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.222 millimeters	Standard Deviation 0.254
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	-0.022 millimeters	Standard Deviation 0.109
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.072 millimeters	Standard Deviation 0.417
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.028 millimeters	Standard Deviation 0.175
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	0.164 millimeters	Standard Deviation 0.194
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	-0.028 millimeters	Standard Deviation 0.107
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	0.092 millimeters	Standard Deviation 0.25
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	-0.019 millimeters	Standard Deviation 0.73
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	2.583 millimeters	Standard Deviation 0.542
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0 millimeters	Standard Deviation 0.047
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	2.350 millimeters	Standard Deviation 2.616
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	2.750 millimeters	Standard Deviation 2.993
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	0.017 millimeters	Standard Deviation 0.024
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	1.20 millimeters	Standard Deviation 1.273
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.017 millimeters	Standard Deviation 0.165
Cohort 10 (Observation Until Documented Growth of Tumor)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.150 millimeters	Standard Deviation 0.071
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	0.013 millimeters	Standard Deviation 0.051
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.017 millimeters	Standard Deviation 0.104
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	0.087 millimeters	Standard Deviation 0.112
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.007 millimeters	Standard Deviation 0.159
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	0.020 millimeters	Standard Deviation 0.119
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.247 millimeters	Standard Deviation 0.315
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	0.147 millimeters	Standard Deviation 0.216
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	1.920 millimeters	Standard Deviation 0.384
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	0.027 millimeters	Standard Deviation 0.13
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 12 (Visit 11)	-0.049 millimeters	Standard Deviation 0.141
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 8 (Visit 4)	0.018 millimeters	Standard Deviation 0.059
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 15 (Visit 6)	0.021 millimeters	Standard Deviation 0.062
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 8 (Visit 10)	-0.010 millimeters	Standard Deviation 0.08
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 52 (Visit 14)	0.128 millimeters	Standard Deviation 0.683
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 26 (Visit 12)	-0.117 millimeters	Standard Deviation 0.4
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Day 29 (Visit 8)	0.018 millimeters	Standard Deviation 0.069
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Week 39 (Visit 13)	-0.039 millimeters	Standard Deviation 0.401
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)	Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Baseline	1.826 millimeters	Standard Deviation 0.604

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study in Subjects With Small Primary Choroidal Melanoma

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011

Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye

Immunogenicity (Anti-AU-011 Antibody Analysis)

Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]

Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]