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The purpose of this study is to evaluate the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes polymorphism in response to the treatments. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV.
Polypoidal choroidal vasculopathy (PCV), a vascular disease of the choroid, appears to be the predominant subtype of exudative or "wet" AMD in Asian populations, in contrast to choroidal neovascularization secondary to AMD (CNV-AMD) in Western populations. There are distinct differences in pathophysiological, clinical and epidemiological factors between the two subtypes, although they also share some common risk factors. In contrast to CNV-AMD, PCV does not seem to respond as well to anti-VEGF treatment. The optimal treatment option for PCV remains elusive, with most studies showing good short-term visual outcome but poorer longer-term outcome with current treatment strategies. Therefore, understanding the pathogenesis of PCV, while developing novel and effective treatments strategies to prevent PCV-related vision loss is significant unmet needs.
The purpose of this study is to assess the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with PCV. Second, the pharmacogenetics effect of inflammatory related genes and polymorphism in response to the treatments of PCV will be explored. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV, it is important to determine the levels of inflammatory factors in the anterior chamber aqueous humor from PCV patients, comparing with the aqueous humor acquired from the age-matched age-related cataract patients undergoing phacoemulsification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab + Triamcinolone Acetonide | Experimental | intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg |
|
| Ranibizumab | Active Comparator | intravitreal injection: Ranibizumab 0.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide | Drug | Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of mean BCVA | Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Central Rerina Thickness | Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months) | 12 months |
| regression of Branch vacular network(BVN) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shibo Tang | Aier School of Ophthalmology, Central South University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Aier Intech Eye Hospital | Beijing | Beijing Municipality | China | |||
| Guangzhou Aier Eye Hospital |
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| Ranibizumab | Drug | Intravitreal inject 0.5mg of Ranibizumab. |
|
|
Size of Branch vascular network (um)
| 12 months |
| Polyps regression | Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months) | 12 months |
| Number of re-treatments | re-treatments numbers | 12 month |
| Guanzhou |
| Guangdong |
| China |
| Shenzhen Aier Eye Hospital | Shenzhen | Guangdong | 510000 | China |
| Shenzhen Eye Hospital | Shenzhen | Guangdong | 528000 | China |
| Harbin Aier Eye Hospital | Harbin | Heilongjiang | China |
| Wuhan General Hospital of PLA | Wuhan | Hubei | China |
| The Eye Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325027 | China |
| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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