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Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma

Primary Purpose

Uveal Melanoma, Choroid Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ICON-1
Sponsored by
Iconic Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveal Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females of any race at least 18 years of age
  • Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
  • Planned enucleation or brachytherapy of the study eye due to uveal melanoma

Exclusion Criteria:

  • Uveal melanoma in the study eye originating in the anterior uveal tract (iris)
  • Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
  • Woman who is pregnant or lactating

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ICON-1 0.3 mg Singe Dose

ICON-1 0.3 mg Repeat Dosing

ICON-1 0.6 mg Repeat Dosing

Arm Description

Patients will receive a single intravitreal dose of ICON-1 0.3 mg

Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart

Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart

Outcomes

Primary Outcome Measures

Occurrence of Adverse Events

Secondary Outcome Measures

Changes in Plasma Levels 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.

Full Information

First Posted
May 6, 2016
Last Updated
September 11, 2020
Sponsor
Iconic Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02771340
Brief Title
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Official Title
A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iconic Therapeutics, Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma, Choroid Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICON-1 0.3 mg Singe Dose
Arm Type
Experimental
Arm Description
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
Arm Title
ICON-1 0.3 mg Repeat Dosing
Arm Type
Experimental
Arm Description
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
Arm Title
ICON-1 0.6 mg Repeat Dosing
Arm Type
Experimental
Arm Description
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
Intervention Type
Biological
Intervention Name(s)
ICON-1
Other Intervention Name(s)
human Immuno-conjugate 1
Intervention Description
Intravitreal injection of ICON-1
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events
Time Frame
30 days (plus or minus 5 days) after surgical procedure
Secondary Outcome Measure Information:
Title
Changes in Plasma Levels of ICON-1.
Time Frame
Baseline to 1 day after last dose of ICON-1
Title
Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study
Description
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.
Time Frame
Baseline to on or 1 day prior to surgical procedure day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females of any race at least 18 years of age Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye Planned enucleation or brachytherapy of the study eye due to uveal melanoma Exclusion Criteria: Uveal melanoma in the study eye originating in the anterior uveal tract (iris) Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia) Woman who is pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela Burian, MD
Organizational Affiliation
Iconic Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.cureom.org
Description
CURE OM (Community United for Research and Education of Ocular Melanoma)
URL
http://www.ocularmelanoma.org
Description
Ocular Melanoma Foundation (OMF)

Learn more about this trial

Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma

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