Trial Outcomes & Findings for Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma (NCT NCT02771340)
NCT ID: NCT02771340
Last Updated: 2020-10-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
30 days (plus or minus 5 days) after surgical procedure
Results posted on
2020-10-01
Participant Flow
Participant milestones
| Measure |
ICON-1 0.3 mg Singe Dose
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.3 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.6 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Baseline characteristics by cohort
| Measure |
ICON-1 0.3 mg Singe Dose
n=2 Participants
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.3 mg Repeat Dosing
n=3 Participants
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.6 mg Repeat Dosing
n=5 Participants
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
82.5 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 15.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days (plus or minus 5 days) after surgical procedureOutcome measures
| Measure |
ICON-1 0.3 mg Singe Dose
n=2 Participants
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.3 mg Repeat Dosing
n=3 Participants
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.6 mg Repeat Dosing
n=5 Participants
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
|---|---|---|---|
|
Occurrence of Adverse Events
Number of Participants with Adverse Events
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Occurrence of Adverse Events
Phototoxic Injury/Surgical Complication
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Adverse Events
Conjunctival Haemorrhage
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Occurrence of Adverse Events
Conjunctival hyperaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Adverse Events
Punctate Keratitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Adverse Events
Iridocyclitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Adverse Events
Intraocular Pressure Increased
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to 1 day after last dose of ICON-1Outcome measures
| Measure |
ICON-1 0.3 mg Singe Dose
n=2 Participants
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.3 mg Repeat Dosing
n=3 Participants
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.6 mg Repeat Dosing
n=5 Participants
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
|---|---|---|---|
|
Changes in Plasma Levels of ICON-1.
|
0 ng/ml-All LLOQ
|
0 ng/ml-All LLOQ
|
0 ng/ml-All LLOQ
|
SECONDARY outcome
Timeframe: Baseline to on or 1 day prior to surgical procedure dayPopulation: End-of-Study assessments obtained for brachytherapy (placing radioactive material in the eye) patients only.
Best-corrected visual acuity (BCVA) will be measured for each eye, pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS)-like retro-illuminated charts. BCVA will be recorded as the total letter score in each eye.
Outcome measures
| Measure |
ICON-1 0.3 mg Singe Dose
n=1 Participants
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.3 mg Repeat Dosing
n=1 Participants
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.6 mg Repeat Dosing
n=2 Participants
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
|---|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study
|
-3 Letters
Standard Deviation 4.2
|
-4.3 Letters
Standard Deviation 11.8
|
-3.6 Letters
Standard Deviation 6.9
|
Adverse Events
ICON-1 0.3 mg Singe Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ICON-1 0.3 mg Repeat Dosing
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
ICON-1 0.6 mg Repeat Dosing
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ICON-1 0.3 mg Singe Dose
n=2 participants at risk
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.3 mg Repeat Dosing
n=3 participants at risk
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.6 mg Repeat Dosing
n=5 participants at risk
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
|---|---|---|---|
|
Eye disorders
Phototoxic Injury/Surgical Complication
|
0.00%
0/2 • During the course of the study and for 30 days last post injection.
|
33.3%
1/3 • Number of events 1 • During the course of the study and for 30 days last post injection.
|
0.00%
0/5 • During the course of the study and for 30 days last post injection.
|
Other adverse events
| Measure |
ICON-1 0.3 mg Singe Dose
n=2 participants at risk
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.3 mg Repeat Dosing
n=3 participants at risk
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
ICON-1 0.6 mg Repeat Dosing
n=5 participants at risk
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1
|
|---|---|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/2 • During the course of the study and for 30 days last post injection.
|
66.7%
2/3 • Number of events 2 • During the course of the study and for 30 days last post injection.
|
60.0%
3/5 • Number of events 3 • During the course of the study and for 30 days last post injection.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/2 • During the course of the study and for 30 days last post injection.
|
33.3%
1/3 • Number of events 1 • During the course of the study and for 30 days last post injection.
|
0.00%
0/5 • During the course of the study and for 30 days last post injection.
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/2 • During the course of the study and for 30 days last post injection.
|
33.3%
1/3 • Number of events 1 • During the course of the study and for 30 days last post injection.
|
0.00%
0/5 • During the course of the study and for 30 days last post injection.
|
|
Eye disorders
Iridocyclitis
|
50.0%
1/2 • Number of events 1 • During the course of the study and for 30 days last post injection.
|
0.00%
0/3 • During the course of the study and for 30 days last post injection.
|
0.00%
0/5 • During the course of the study and for 30 days last post injection.
|
|
Eye disorders
Intraocular Pressure Increased
|
50.0%
1/2 • Number of events 1 • During the course of the study and for 30 days last post injection.
|
0.00%
0/3 • During the course of the study and for 30 days last post injection.
|
40.0%
2/5 • Number of events 2 • During the course of the study and for 30 days last post injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place