NCT03452527
Terminated
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Choroidal Neovascularization
- Sponsor
- Iconic Therapeutics, Inc.
- Enrollment
- 15
- Locations
- 8
- Primary Endpoint
- Change in Choroidal Neovascularization (CNV) Over Time
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Choroidal Neovascularization (CNV) Over Time
Time Frame: Month 9
Mean change from baseline in CNV area in the study eye
Secondary Outcomes
- Change in Best Corrected Visual Acuity (BCVA) Over Time(Month 9)
Study Sites (8)
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