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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept 8 mg | Experimental | The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T&E phase thereafter. In the T&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept 8 mg | Drug | The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T&E phase thereafter. In the T&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Last injection interval at week 96 | Week 96 | |
| Best corrected visual acuity (BCVA) at weet 96 | Measurement with the Early Treatment Diabetic Retinopathy Study (ETDRS) letters score | Week 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sohee Shin | Contact | 82-53-620-3440 | ey005@ymc.yu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University Hospital | Recruiting | Daegu | 42415 | South Korea |
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| Central retinal thickness and choroidal thickness at week 96 | Average retinal thickness at the central 1 mm diameter | Week 96 |
| umber of participants with treatment-related adverse events | Slit lamp examination and fundoscopy | Week 96 |
| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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