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To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITV-1 | Experimental | VEGF Trap formulation 1 |
|
| ITV-2 | Experimental | VEGF Trap formulation 2 |
|
| ITV-2 OL | Experimental | VEGF Trap formulation 2 open label, higher concentration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEGF Trap | Drug | VEGF Trap formulation 1, ITV-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
No prior treatment with the following in the study eye:
History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
Significant subfoveal atrophy or scarring.
Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
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| Name | Affiliation | Role |
|---|---|---|
| Avner Ingerman, MD | Regeneron Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Myers | Florida | 33907 | United States | |||
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| VEGF Trap | Biological | VEGF Trap formulation 2 at higher concentration in Open label cohort |
|
|
| Wichita |
| Kansas |
| 67214 |
| United States |
| Hagerstown | Maryland | 21740 | United States |
| Columbia | South Carolina | 29169 | United States |
| Austin | Texas | 78705 | United States |
| McAllen | Texas | 78503 | United States |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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