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The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVT injection once every 8 weeks after 3 initial monthly doses | Other | Intravitreal aflibercept injection 2.0mg dosed every 4 weeks (monthly)for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection every eight weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of greater than or equal to 5 letters from the previous visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYLEA (Aflibercept) intravitreal injection | Drug | Intravitreal Injection once every 8 weeks with 3 initial monthly doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The Incidence & Severity will be assessed during study participation. Baseline medical conditions & abnormal findings present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit,and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean visual acuity (BCVA) at Months 6 and 12 | Month 6 and Month 12 | |
| Mean change in OCT central foveal thickness from baseline at Months 6 and 12 | Months 6 and 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin J Blinder, MD | The Retina Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Retina Institute | St Louis | Missouri | 63017 | United States | ||
| The Retina Institute |
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| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D058449 | Intravitreal Injections |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| Mean change in Macular Volume from baseline at Months 6 and 12 |
| Months 6 and 12 |
| Mean change in visual acuity (BCVA) from baseline at Months 6 and 12 | Months 6 and 12 |
| Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12 | Months 6 and 12 |
| Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12 | Months 6 and 12 |
| St Louis |
| Missouri |
| 63128 |
| United States |
| The Retina Institute | St Louis | Missouri | 63144 | United States |
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |