Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT05639660
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2022-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Implication of Aflibercept in PCV Treatment in China
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Aflibercept Observational Study for the Clinical Use of PCV in China, Polycentric, Observational, Retrospective-prospective Study
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Main evaluation indicators: To observe the changes in visual acuity (BCVA) in PCV patients treated with Aflibercept to evaluate the effectiveness of the treatment.
Detailed Description:
Primary Study Objective(s) To provide overall treatment characteristics of aflibercept in PCV treatment Secondary Study Objective(s)
1. To describe the treatment regimens of aflibercept treatment on PCV in clinical practice.
2. To evaluate effectiveness of aflibercept treatment on PCV including vision gain (BCVA) and anatomic improvement (CRT, Polyps regression, Polyps inactivity, and PED)
3. To explore the relative factors of aflibercept treatment effectiveness.
4. To describe patients' tolerance to anti-VEGF and PDT treatment.
5. To collect safety information with aflibercept treatment in a wider population setting
1. To describe the treatment regimens of aflibercept treatment on PCV in clinical practice.
2. To evaluate effectiveness of aflibercept treatment on PCV including vision gain (BCVA) and anatomic improvement (CRT, Polyps regression, Polyps inactivity, and PED)
3. To explore the relative factors of aflibercept treatment effectiveness.
4. To describe patients' tolerance to anti-VEGF and PDT treatment.
5. To collect safety information with aflibercept treatment in a wider population setting
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: