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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The goal of this clinical trial is to investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are:
Participants will:
This study will assess the efficacy, safety and durability of aflibercept 8mg in these 2 regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other | All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). Subsequent reinjections will be given according to the changes in patients' disease activity. If no retreatment criteria are met, no additional injections will be given, and patients will undergo follow-up examinations (including ETDRS visual acuity, findus photography, OCT-A and SD-OCT) every 4 weeks until week 48. Patients will return to the Clinical Research Unit (CRU) for an end-of-study (EOS) visit at week 52. |
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| Arm B | Other | All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). All patients in this group will undergo an examination at week 12, including ETDRS visual acuity, fundus photography, OCT-A and SD-OCT. Subsequent treatment regime will depend on disease activity. If disease is considered inactive, the next dose will occur at week 16 (8 week interval from last dose at week 8) and subsequent dose and visit will be extended by 4 weeks up to a maximum interval of 20 weeks and minimum interval of 8 weeks between treatments if disease remains quiescent. If signs of activity are noted at any visit point, visit interval will be reduced by 4 weeks. The last dose will be administered no later than week 48. Patients will return to the CRU for an EOS visit at week 52. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Intravitreous Injection | Drug | Patients will be given IVT injection(s) of IMP using standard injection techniques. |
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| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens. | BCVA (study eye and the fellow eye) examination | up to 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients gaining >15, >10, or ≥5 letters in BCVA after baseline | BCVA (study eye and the fellow eye) examination | up to 52 Weeks |
| Percentage of patients achieving complete polypoidal lesion regression at Weeks 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Sun | Contact | +86-13651765503 | xdsun@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China |
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SD-OCT Spectral Domain Optical Coherence Tomography, FA Fluorescein Angiography, ICGA Indocyanine Green Angiography, OCT-A Optical Coherence Tomography Angiography, FP Fundus Photography examinations
| up to 52 Weeks |
| Percentage of patients with no active polypoidal lesion at Week 52 | SD-OCT Spectral Domain Optical Coherence Tomography, FA Fluorescein Angiography, ICGA Indocyanine Green Angiography, OCT-A Optical Coherence Tomography Angiography, FP Fundus Photography examinations | up to 52 Weeks |
| Change from baseline in central subfield thickness (CST) at Week 12 and 52. | SD-OCT Spectral Domain Optical Coherence Tomography examination | up to 12 and 52 Weeks |
| BCVA change from baseline at Week 12 | BCVA (study eye and the fellow eye) examination | up to 12 Weeks |
| Percentage of patients achieving Q8W, Q12W, and Q16W treatment intervals at Week 52 in Arm B. | Calculating the ratio | up to 52 Weeks |
| Percentage of patients achieving Q20W of last assigned interval at Week 52 in Arm B. | Calculating the ratio | up to 52 Weeks |
| Percentage of patients achieving ≥12-week, ≥16-week and ≥20-week treatment intervals after completing loading doses in Arm A. | Calculating the ratio | up to 52 Weeks |
| Total number of intravitreal injections administered through Week 52 in both arms. | Counting | up to 52 Weeks |
| Incidence and severity of ocular & non-ocular adverse events. | Recording of adverse events | up to 52 Weeks |
| Beijing Tongren Hospital, CMU | Beijing | Beijing Municipality | China |
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| The Second People's Hospital Of Foshan | Foshan | Guangdong | China |
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| The First Affiliated Hospital Of Harbin Medical University | Harbin | Heilongjiang | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| Renmin Hospital Of Wuhan University | Wuhan | Hubei | China |
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| Jiangsu Province Hospital , The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | China |
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| Affiliated Eye Hospital of Nanchang University | Nanchang | Jiangxi | China |
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| The Second Norman Bethune Hospital Of Jilin University | Jilin City | Jilin | China |
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| Xi' AN No.1 Hospital | Xi'an | Shaanxi | China |
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| The First People's Hospital Of Xianyang | Xianyang | Shaanxi | China |
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| Shandong Provincial Hospital | Jinan | Shandong | China |
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| Affiliated Hospital Of Shandong Second Medical University | Weifang | Shandong | China |
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| Eye & ENT Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
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| Shanxi Eye Hospital | Taiyuan | Shanxi | China |
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| Tianjin Eye Hospital | Tianjin | Tianjin Municipality | China |
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| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunan | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| Jiaxing Hospital of T.C.M | Jiaxing | Zhejiang | China |
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| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| 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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