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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV
This is an open-label, randomized, one-year, multiple-dose study of 2mg aflibercept in patients with PCV.
The study consists of the baseline visit on day 0 and a mandatory clinic visit every 30 days to assess efficacy and safety. All patients will receive three monthly injections of 2mg intravitreal aflibercept injection followed by treatment every 60 days through 720 days (24 months). Patients can be treated every 30 days if needed.
The fellow eye may be treated with intravitreal aflibercept injection per the investigator's discretion at any point during the study if evidence of disease activity are met: exudation or hemorrhage secondary to polypoidal choroidal vasculopathy or exudative AMD. The fellow eye will not be considered the study eye. If treatment with aflibercept is to be given in the fellow eye, the injections are to be administered according to the Food and Drug Administration (FDA) approved label for EYLEA®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously Treated | Active Comparator | Patients that have previously received treatment for polypoidal choroidal vasculopathy. Intervention: Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for previously treated arm. |
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| Treatment-Naive | Active Comparator | Patients that have not received treatment for polypoidal choroidal vasculopathy. Intervention: Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for treatment-naive arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal aflibercept injection 2.0mg | Drug | Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for both treatment naive and prior treatment arms. |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of intravitreal aflibercept injection of 2.0mg aflibercept | This study will evaluate the efficacy of intravitreal aflibercept injection of 2.0mg aflibercept administered Q8W following an initial loading dose of 3 monthly injections in patients with polypoidal choroidal vasculopathy with active exudation or bleeding as measured by: • Mean change in BCVA between Day 0 (Baseline) and Day 720 (M24) | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients with Stable, Improved, Significant Improved, Decreased, Significant Decreased Vision | To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) with "Stable" vision <5 letters gained or lost, "Improved" vision >5 letters gained, "Significant Improved" vision ≥15 letters gained, "Decreased" vision >5 letters lost, "Significant Decreased" vision ≥15 letters lost |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregg T. Kokame, MD, MMS | Hawaii Pacific Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27465105 | Derived | Kokame GT, Lai JC, Wee R, Yanagihara R, Shantha JG, Ayabe J, Hirai K. Prospective clinical trial of Intravitreal aflibercept treatment for PolypoIdal choroidal vasculopathy with hemorrhage or exudation (EPIC study): 6 month results. BMC Ophthalmol. 2016 Jul 27;16:127. doi: 10.1186/s12886-016-0305-2. |
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| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| 6 Months, 12 Months, 18 Months, 24 Months |
| Proportion of Patients with decrease in Subretinal Hemorrhage and/or Exudates | To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18), Day 720 (M24) in decreasing subretinal hemorrhage and/or subretinal exudates via fundus photos and fundus exams | Month 6, Month 12, Month 18, Month 24 |
| Proportion of patients with decreased / complete resolution of Polypoidal Polyp. | To evaluate the proportion of subjects with a decrease and/or complete resolution of polypoidal polyps from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) as assessed by fluorescein and indocyanine green angiography | Month 3, Month 6, Month 12, Month 18, Month 24 |
| Proportion of subject with a decrease or complete resolution of branching vascular network from PCV | To identify the proportion of subjects with a decrease and/or complete resolution of branching vascular network (BVN) from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24) months as assessed by fluorescein and indocyanine green angiography | Month 3, Month 6, Month 12, Month 18, Month 24 |
| Determine mean change in Central Foveal Thickness and/or peripapillary edema as measured by SD-OCT | To determine mean change in central foveal thickness (CFT) and/or peripapillary edema as measured by spectral domain optical coherence tomography (SD-OCT) in central and/or paracentral fields from Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24) | Baseline, Month 6, Month 12, Month 18, Month 24 |
| Mean Change in Choroidal Thickness | To determine mean change in choroidal thickness (at fovea) as imaged via EDI-OCT between Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18), and Day 720 (M24) | Baseline, Month 6, Month 12, Month 18, Month 24 |
| Proportion of previously treated and treatment naive patients that require additional dosing outside of the protocol determined dosing schedule | To identify proportion of patients between previously treated and treatment naïve patients that require additional dosing outside of the protocol determined dosing schedule: 3- initial monthly dosing followed by dosing every other month for 720 days (M24) | Month 24 |
| Assess changes on Autofluorescence | To assess changes on autofluorescence (AF) as seen on images from Day 1 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) | Baseline, Month 6, Month 12, Month 18, Month 24 |
| Incidence and Severity of Ocular and Non-Ocular Adverse Events | To determine the incidence and severity of ocular and non-ocular adverse events from Day 1(Baseline) through the end of the study (Day 720) | Baseline through Month 24 |
| D009389 |
| Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |