Trial Outcomes & Findings for Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma (NCT NCT03712904)

NCT ID: NCT03712904

Last Updated: 2025-09-24

Results Overview

Percent of patients who experience Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 toxicity related to SRT and/or intravitreal Aflibercept.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to approximately 6 months
• Results posted on: 2025-09-24

Participant Flow

Participant milestones

Measure	A. Stereotactic Body Radiation Therapy, Ziv-aflibercept Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo radiation	B. Stereotactic Body Radiation Therapy, Ziv-aflibercept Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Ziv-Aflibercept: Given IV
Overall Study STARTED	1	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	A. Stereotactic Body Radiation Therapy, Ziv-aflibercept Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo radiation	B. Stereotactic Body Radiation Therapy, Ziv-aflibercept Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Ziv-Aflibercept: Given IV
Overall Study Death	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study progression/eye removed before 2 years (unable to complete testing)	1	0

Baseline Characteristics

Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma

Baseline characteristics by cohort

Measure	A. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=1 Participants Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo radiation	B. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=2 Participants Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Ziv-Aflibercept: Given IV	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 6 months

Percent of patients who experience Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 toxicity related to SRT and/or intravitreal Aflibercept.

Outcome measures

Measure	A. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=1 Participants Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo radiation	B. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=2 Participants Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Ziv-Aflibercept: Given IV
Incidence of Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At 2 years

Population: No participants were evaluable for this outcome. One participant withdrew consent, one experienced disease progression requiring eye removal prior to the assessment time point, and one died before reaching the two year mark. Subject who died was no longer a patient at the institution and their death was found through obituary search.

Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 years

Population: No participants were evaluable for this outcome. One participant withdrew consent, one experienced disease progression requiring eye removal prior to the assessment time point, and one died before reaching the two year mark. Subject who died was no longer a patient at the institution and their death was found through obituary search.

Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.

Outcome measures

Outcome data not reported

Adverse Events

A. Stereotactic Body Radiation Therapy, Ziv-aflibercept

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

B. Stereotactic Body Radiation Therapy, Ziv-aflibercept

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	A. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=1 participants at risk Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo radiation	B. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=2 participants at risk Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Ziv-Aflibercept: Given IV
Eye disorders Retinal detachment - Grade 3	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
General disorders Death	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Other adverse events

Measure	A. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=1 participants at risk Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo radiation	B. Stereotactic Body Radiation Therapy, Ziv-aflibercept n=2 participants at risk Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Ziv-Aflibercept: Given IV
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Cardiac disorders Atrial Fibrillation - Grade 3	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
General disorders Bloating - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Blurred Vision - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	100.0% 2/2 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Cardiac disorders Cardiac Myopathy - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Cataract - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Hepatobiliary disorders Chronic Kidney Disease - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Cardiac disorders Coronary Artery Disease - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Vascular disorders Dyspnea - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Episcleritis - eye - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Skin and subcutaneous tissue disorders Erythma - face - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Eye Hemorrhage - Grade 2	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	100.0% 2/2 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Eye Pain - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	100.0% 2/2 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
General disorders Fatigue - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Flashing lights - eye - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Floaters - Eye - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Vascular disorders Focal dissection in right hepatic artery - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Foreign body sensation - eye - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Ear and labyrinth disorders Hearing impairment - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Musculoskeletal and connective tissue disorders Hernia - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Blood and lymphatic system disorders Hyperglycemia - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Vascular disorders Hypertension - Grade 3	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	100.0% 2/2 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Metabolism and nutrition disorders Impaired fasting glucose - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Ear and labyrinth disorders Impaired Hearing - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Hepatobiliary disorders Hyperkalemia - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Left Eye Buckle - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Left eye superior arc worse - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Blood and lymphatic system disorders Microcytic anemia - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Cardiac disorders Myelodysplastic Syndrome - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Nuclear sclerosis - both eyes - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Musculoskeletal and connective tissue disorders Osteoarthritis - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
General disorders Pain - Back - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Periorbital changes - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Musculoskeletal and connective tissue disorders Peripheral sensory neuropathy - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Skin and subcutaneous tissue disorders Photophobia - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Redness - Eye - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Hepatobiliary disorders Renal insufficiency - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Retinal detachment - Grade 2	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Retinal detachment - Grade 3	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Right Eye Cystoid Macular Edema - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	50.0% 1/2 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Musculoskeletal and connective tissue disorders Spinal stenosis - lumbar region - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Subretinal Fluid - Grade 1	0.00% 0/1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	100.0% 2/2 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
General disorders Swelling - Eye - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Ear and labyrinth disorders Tinnitus - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Vision decreased - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0.00% 0/2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eye disorders Visual field defect - Grade 1	100.0% 1/1 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	100.0% 2/2 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months. Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Additional Information

Wenyin Shi, MD, PhD

Thomas Jefferson University

Phone: (215) 955-6702

Email: wenyin.shi@jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place