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NCT03452527 Clinical Trial

Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

Choroidal Neovascularization Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03452527
Other study ID # IT-004
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 26, 2018
Est. completion date April 25, 2019

Study information
Verified date November 2020
Source Iconic Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 15
Est. completion date April 25, 2019
Est. primary completion date April 25, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ICON-1
ICON-1 0.6 mg by intravitreal injection
• aflibercept
aflibercept 2 mg by intravitreal injection

Locations
Country Name City State
United States Site 3 Ashland Oregon
United States Site 1 Austin Texas
United States Site 2 Beverly Hills California
United States Site 4 McAllen Texas
United States Site 6 Philadelphia Pennsylvania
United States Site 5 San Antonio Texas
United States Site 8 Santa Ana California
United States Site 7 Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
Iconic Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Choroidal Neovascularization (CNV) Over Time Mean change from baseline in CNV area in the study eye Month 9
Secondary Change in Best Corrected Visual Acuity (BCVA) Over Time Mean change from baseline in BCVA letter score in the study eye Month 9
See also
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Recruiting NCT00100087 - Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System Phase 1/Phase 2
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Completed NCT01880788 - Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD N/A
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Completed NCT00406250 - Intravitreal Bevacizumab in Agioid Streaks Phase 1
Withdrawn NCT00403156 - Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration Phase 1