Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Part of paid clinical trials in Beverly Hills, California.
- Sponsor
- Iconic Therapeutics, Inc.
- Study ID
- NCT03452527
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Choroidal Neovascularization
- Wet Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ICON-1 — BIOLOGICALICON-1 0.6 mg by intravitreal injection
- aflibercept — BIOLOGICALaflibercept 2 mg by intravitreal injection
Study Details
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.
Key Dates
- First listed
- Mar 2, 2018
- Start date
- Mar 26, 2018
- Status verified
- Nov 2020
- Primary completion
- Apr 25, 2019
- Completion
- Apr 25, 2019
Study Design
- Enrollment
- 15 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ICON-1 maintenance therapyICON-1 maintenance therapy after initial aflibercept treatment
- Experimental: ICON-1 combination therapyICON-1 combination therapy with aflibercept treatment
Primary Outcome Measure
Change in Choroidal Neovascularization (CNV) Over Time [ Time Frame: Month 9 ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site 2 | Beverly Hills | California | 90211 | - |
| Site 8 | Santa Ana | California | 92705 | - |
| Site 7 | Syracuse | New York | 13224 | - |
| Site 3 | Ashland | Oregon | 97520 | - |
| Site 6 | Philadelphia | Pennsylvania | 19107 | - |
| Site 1 | Austin | Texas | 78705 | - |
| Site 4 | McAllen | Texas | 78503 | - |
| Site 5 | San Antonio | Texas | 78240 | - |
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