Choroidal Neovascularization Clinical Trial
— DECOOfficial 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
Verified date | November 2020 |
Source | Iconic Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Iconic Therapeutics, Inc. |
United States,
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 |
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