Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Phase 2
Terminated
- Conditions
- Choroidal NeovascularizationWet Macular Degeneration
- Registration Number
- NCT03452527
- Lead Sponsor
- Iconic Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Choroidal Neovascularization (CNV) Over Time Month 9 Mean change from baseline in CNV area in the study eye
- Secondary Outcome Measures
Name Time Method Change in Best Corrected Visual Acuity (BCVA) Over Time Month 9 Mean change from baseline in BCVA letter score in the study eye
Trial Locations
- Locations (8)
Site 2
🇺🇸Beverly Hills, California, United States
Site 8
🇺🇸Santa Ana, California, United States
Site 7
🇺🇸Syracuse, New York, United States
Site 3
🇺🇸Ashland, Oregon, United States
Site 6
🇺🇸Philadelphia, Pennsylvania, United States
Site 1
🇺🇸Austin, Texas, United States
Site 4
🇺🇸McAllen, Texas, United States
Site 5
🇺🇸San Antonio, Texas, United States
Site 2🇺🇸Beverly Hills, California, United States