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The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravitreal aflibercept injection | Experimental | Group A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection. . |
|
| intravitreal aflibercept | Experimental | Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| ocular and systemic adverse events | The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12 | through Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity |
| Months 3, 6, 9 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| OCT changes | Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT | baseline to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Holcomb, COA | Contact | 859-264-2905 | dholcomb@retinaky.com |
| Name | Affiliation | Role |
|---|---|---|
| John W Kitchens, MD | Retina Associates of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Retina | Recruiting | Augusta | Georgia | 30909 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006660 | Histoplasmosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Retina Associates of Kentucky | Recruiting | Lexington | Kentucky | 40509 | United States |
|
| Cincinnati Eye Institute | Recruiting | Cincinnati | Ohio | 45242 | United States |
|