Study Stopped
Business Reasons
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
DECO
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
1 other identifier
interventional
15
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2018
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 2, 2018
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2019
CompletedResults Posted
Study results publicly available
March 15, 2021
CompletedApril 13, 2021
November 1, 2020
1.1 years
February 26, 2018
September 1, 2020
March 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Choroidal Neovascularization (CNV) Over Time
Mean change from baseline in CNV area in the study eye
Month 9
Secondary Outcomes (1)
Change in Best Corrected Visual Acuity (BCVA) Over Time
Month 9
Study Arms (2)
ICON-1 maintenance therapy
EXPERIMENTALICON-1 maintenance therapy after initial aflibercept treatment
ICON-1 combination therapy
EXPERIMENTALICON-1 combination therapy with aflibercept treatment
Interventions
ICON-1 0.6 mg by intravitreal injection
aflibercept 2 mg by intravitreal injection
Eligibility Criteria
You may qualify if:
- Males or females of any race, ≥50 years of age
- Active primary CNV secondary to AMD in the study eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Site 2
Beverly Hills, California, 90211, United States
Site 8
Santa Ana, California, 92705, United States
Site 7
Syracuse, New York, 13224, United States
Site 3
Ashland, Oregon, 97520, United States
Site 6
Philadelphia, Pennsylvania, 19107, United States
Site 1
Austin, Texas, 78705, United States
Site 4
McAllen, Texas, 78503, United States
Site 5
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gabriela Burian, M.D.
- Organization
- Iconic Therapeutics
Study Officials
- STUDY DIRECTOR
Gabriela Burian, MD
Iconic Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2018
First Posted
March 2, 2018
Study Start
March 26, 2018
Primary Completion
April 25, 2019
Study Completion
April 25, 2019
Last Updated
April 13, 2021
Results First Posted
March 15, 2021
Record last verified: 2020-11