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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohorts 1 through 4 | Experimental | Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI |
|
| Cohort 5 | Experimental | Participants in cohort 5 will receive IVT REGN910 and IAI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN910-3 | Drug |
| ||
| REGN910 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 | Change from baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile | PK profile may include, but is not limited to, the following:
|
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Key Inclusion Criteria:
For patients with AMD:
For patients with DME:
Key Exclusion Criteria:
For patients with neovascular AMD:
For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
Prior IAI in either eye
IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an AE with any of these previous treatments that would preclude administration of drug in this study
Any prior treatment with angiopoietin inhibitors
Any prior systemic (IV) anti-VEGF administration
History of vitreoretinal surgery in the study eye
Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit
Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening
(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
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|
| Intravitreal Aflibercept Injection (IAI) | Drug |
|
|
| Baseline to week 24 |
| Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3 | Baseline to week 24 |
| Winter Haven |
| Florida |
| United States |
| Boston | Massachusetts | United States |
| West Columbia | South Carolina | United States |
| Abilene | Texas | United States |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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