Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.

Detailed Description
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PCV is generally recognized as a subtype of wet AMD characterized by the presence of aneurysmal orange-red polypoidal lesions with or without branching vascular network (BVN) in the choroidal vasculature as observed on indocyanine angiography (ICGA), representing 13% to 54.7% of newly diagnosed patients with neovascular AMD. Fifty percent of PCV had persistent leakage or recurrent bleeding with poor visual outcome, if left untreated. And in the EVEREST study has shown that synergistic effects of anti-VEGF and vPDT combination: vPDT strongly regress polyp and anti-VEGF control to up-regulation of VEGF induced by vPDT compared to ranibizumab monotherapy in newly diagnosed PCV patients. Additionally, combination offers an opportunity for individualized treatment with potentially fewer treatments and less costs. Therefore, the aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.

Official Title
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Comparison of Early Intervention of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV Patients With Initial Loading Dose

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Procedure: PDT
* Drug: Ranibizumab
* Drug: ranibizumab PRN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or older than 50 years Insufficient responder to ranibizumab Tx ICGA-confirmed PCV BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts Ability to provide written informed consent and comply with study assessments for the full duration of the study Exclusion Criteria: Prior treatment with other anti-VEGF treatments in the study eye. Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye. Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye. Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye Previous submacular surgery in the study eye A history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia Experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma Previous participation in a clinical trial involving anti-angiogenic drugs Intraocular surgery: 2 months before Visit 1 in the study eye. Previous participation in any studies of investigational drugs Administration of periocular, intravitreal, or systemic corticosteroid in the previous 3 months.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: combination Tx<br>combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6) | Procedure: PDT<br>* PDT and ranibizumab<br>Drug: ranibizumab PRN<br>* ranibizumab PRN<br>* Other names: Lucentis;|
| Other: mono Tx<br>Ranibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6) | Drug: Ranibizumab<br>* Ranibizumab<br>* Other names: Lucentis;Drug: ranibizumab PRN<br>* ranibizumab PRN<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central retinal thickness | Change in central retinal thickness measured by OCT | after 6month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ETDRS BCVA | Change of ETDRS BCVA from baseline to 26 weeks and time course of it | after 6month |