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The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT) administration of DE-120 in subjects with treatment-naive active subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-120 Monotherapy | Experimental | DE-120 intravitreal injection given as monotherapy on a PRN basis |
|
| Eylea® and DE-120 Concomitant Therapy | Experimental | DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-120 | Drug |
| ||
| Aflibercept |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in BCVA at Month 8 | Month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total lesion area at Month 8 | Month 8 | |
| Change from baseline in greatest linear dimension of the area of leakage at Month 8 | Month 8 | |
| Change in Central Subfield Thickness at Month 8 |
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Inclusion Criteria:
Exclusion Criteria:
Ocular
Non-Ocular
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| Drug |
|
|
| Month 8 |
| Bakersfield |
| California |
| United States |
| Walnut Creek | California | United States |
| Golden | Colorado | United States |
| Altamonte Springs | Florida | United States |
| Fort Myers | Florida | United States |
| Indianapolis | Indiana | United States |
| Portsmouth | New Hampshire | United States |
| Charlotte | North Carolina | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| McAllen | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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