Back to resultsOpen-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD) (DECO)
Primary Purpose
Choroidal Neovascularization, Wet Macular Degeneration
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ICON-1
aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Choroidal Neovascularization
Eligibility Criteria
Inclusion Criteria:
- Males or females of any race, ≥50 years of age
- Active primary CNV secondary to AMD in the study eye
Exclusion Criteria:
- Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
- Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
- Vitrectomy in the study eye
Sites / Locations
- Site 2
- Site 8
- Site 7
- Site 3
- Site 6
- Site 1
- Site 4
- Site 5
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ICON-1 maintenance therapy
ICON-1 combination therapy
Arm Description
ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1 combination therapy with aflibercept treatment
Outcomes
Primary Outcome Measures
Change in Choroidal Neovascularization (CNV) Over Time
Mean change from baseline in CNV area in the study eye
Secondary Outcome Measures
Change in Best Corrected Visual Acuity (BCVA) Over Time
Mean change from baseline in BCVA letter score in the study eye
Full Information
NCT ID
NCT03452527
First Posted
February 26, 2018
Last Updated
March 21, 2021
Sponsor
Iconic Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03452527
Brief Title
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Acronym
DECO
Official Title
A Phase 2 Randomized, Open-Label, Multicenter Study Evaluating Administration of Repeated Intravitreal Doses of ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Business Reasons
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iconic Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Wet Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICON-1 maintenance therapy
Arm Type
Experimental
Arm Description
ICON-1 maintenance therapy after initial aflibercept treatment
Arm Title
ICON-1 combination therapy
Arm Type
Experimental
Arm Description
ICON-1 combination therapy with aflibercept treatment
Intervention Type
Biological
Intervention Name(s)
ICON-1
Other Intervention Name(s)
human Immuno-conjugate 1
Intervention Description
ICON-1 0.6 mg by intravitreal injection
Intervention Type
Biological
Intervention Name(s)
aflibercept
Other Intervention Name(s)
Eylea®
Intervention Description
aflibercept 2 mg by intravitreal injection
Primary Outcome Measure Information:
Title
Change in Choroidal Neovascularization (CNV) Over Time
Description
Mean change from baseline in CNV area in the study eye
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity (BCVA) Over Time
Description
Mean change from baseline in BCVA letter score in the study eye
Time Frame
Month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females of any race, ≥50 years of age
Active primary CNV secondary to AMD in the study eye
Exclusion Criteria:
Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
Vitrectomy in the study eye
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:
Facility Name
Site 2
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Site 8
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Site 7
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Site 3
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Site 6
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Site 1
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site 4
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Site 5
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
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