Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)
Part of paid clinical trials in Beverly Hills, California.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT01997164
- Phase
- PHASE1
- Status
- Completed
Conditions
- Diabetic Macular Edema
- Neovascular Age-Related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- REGN910-3 — DRUG
- REGN910 — DRUG
- Intravitreal Aflibercept Injection (IAI) — DRUG
Study Details
The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).
Key Dates
- Start date
- Nov 30, 2014
- Status verified
- Jan 2016
- Primary completion
- Oct 31, 2015
- Completion
- Oct 31, 2015
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Cohorts 1 through 4Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI
- Experimental: Cohort 5Participants in cohort 5 will receive IVT REGN910 and IAI
Primary Outcome Measure
Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Change from baseline to week 24 ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Beverly Hills | California | - | - |
| - | Winter Haven | Florida | - | - |
| - | Boston | Massachusetts | - | - |
| - | West Columbia | South Carolina | - | - |
| - | Abilene | Texas | - | - |
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