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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this study is to evaluate the overall treatment characteristics and efficacy of Aflibercept in the treatment of PCV in China through a multicenter, observational, prospective-retrospective study. This study is a long-term follow-up cohort, plans to unite a total of 30 hospitals in different regions of the China to enroll 1000 PCV patients.
Main evaluation indicators: To observe the changes in visual acuity (BCVA) in PCV patients treated with Aflibercept to evaluate the effectiveness of the treatment.
Primary Study Objective(s) To provide overall treatment characteristics of aflibercept in PCV treatment Secondary Study Objective(s)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept group | Single arm, Aflibercept 2.0mg/0.05ml, intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-interventional | Other | The treatment guideline recommends the 3+Q2m regimen for Aflibercept, but this study is an observational study, no intervention is made in the subjects' treatment regimen. There is no prescribed visit plan. According to the decision of the doctor and the patient according to the treatment plan, the patient needs to come to the clinic within the prescribed time window (3, 6, and 12 months) to facilitate the recording of data. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mean BCVA from baseline at the month 3, 6, 12 | Routine International standard visual acuity chart, best corrected visual acuity | Through study completion, 1 year |
| Mean treatment pattern of aflibercept in PCV treatment | To describe the mean treatment pattern of aflibercept in PCV treatment | Through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with each treatment regimen | based on different count and describe the patients' proportion | Through study completion, 1 year |
| Change in CRT from baseline at month 3, 6, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed as polypoid choroidal vasculopathy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youxin Chen, Professor | Contact | +86 13801025972 | chenyx@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Youxin Chen, Professor | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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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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|
Non-contact intraocular pressure before and after study eye injection, study eye slit lamp, ophthalmoscopy, identify the change of CRT
| Through study completion, 1 year |
| Proportion of patients with complete regression of polyps at month 3, 6, 12 | color fundus photography of the research eye, study eye ICGA angiography | Through study completion, 1 year |
| Proportion of patients with inactivity polyps at month 3, 6, 12 | color fundus photography of the research eye, study eye ICGA angiography | Through study completion, 1 year |
| Proportion of patients with dry retina at month 3, 6 and 12 | OCT, OCTA examination, color fundus photography of the research eye | Through study completion, 1 year |
| Proportion of patients with PED regression at month 3, 6 and 12 | OCT, OCTA examination | Through study completion, 1 year |
| Mean of treatment interval and number of injections at month 12 | Observe and describe the treatment pattern during routine follow-up visits | Through study completion, 1 year |
| Inactive polyp evaluation by OCTA at month 3, 6, 12 | OCTA examination during follow-up visits | Through study completion, 1 year |
| D009389 |
| Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |