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The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICON-1 0.3 mg Singe Dose | Experimental | Patients will receive a single intravitreal dose of ICON-1 0.3 mg |
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| ICON-1 0.3 mg Repeat Dosing | Experimental | Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart |
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| ICON-1 0.6 mg Repeat Dosing | Experimental | Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICON-1 | Biological | Intravitreal injection of ICON-1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events | 30 days (plus or minus 5 days) after surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Plasma Levels of ICON-1. | Baseline to 1 day after last dose of ICON-1 | |
| Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Burian, MD | Iconic Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | 94109 | United States | |||
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| Label | URL |
|---|---|
| CURE OM (Community United for Research and Education of Ocular Melanoma) | View source |
| Ocular Melanoma Foundation (OMF) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2016 |
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| Baseline to on or 1 day prior to surgical procedure day |
| Denver |
| Colorado |
| 80401 |
| United States |
| Leawood | Kansas | 66211 | United States |
| Boston | Massachusetts | 02114 | United States |
| Grand Rapids | Michigan | 49546 | United States |
| Royal Oak | Michigan | 48073 | United States |
| Portland | Oregon | 97239 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Adverse Events | Posted | Count of Participants | Participants | 30 days (plus or minus 5 days) after surgical procedure |
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| Secondary | Changes in Plasma Levels of ICON-1. | Posted | Number | ng/ml-All LLOQ | Baseline to 1 day after last dose of ICON-1 |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study | 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. | End-of-Study assessments obtained for brachytherapy (placing radioactive material in the eye) patients only. | Posted | Mean | Standard Deviation | Letters | Baseline to on or 1 day prior to surgical procedure day |
|
During the course of the study and for 30 days last post injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 2 | 0 | 2 | 1 | 2 |
| EG001 | 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 | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 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 | 0 | 5 | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phototoxic Injury/Surgical Complication | Eye disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Eye disorders | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
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| Punctate Keratitis | Eye disorders | Systematic Assessment |
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| Iridocyclitis | Eye disorders | Systematic Assessment |
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| Intraocular Pressure Increased | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Burian, M.D. | Iconic Therapeutics | 6504371000 | gburian@iconictherapeutics.com |
| Aug 18, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D002830 | Choroid Neoplasms |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D015862 | Choroid Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Conjunctival Haemorrhage |
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| Conjunctival hyperaemia |
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| Punctate Keratitis |
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| Iridocyclitis |
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| Intraocular Pressure Increased |
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| Units | Counts |
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| Participants |
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