Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen

Study Overview
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Brief Summary
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The aim of this study is to compare the outcomes of different treatment methods including photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the 1+PRN treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the optimal treatment for PCV.

Detailed Description
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The optimal treatment for PCV is still under debate. Little knowledge is known about the treatment effect of 1+pro re nata(PRN) treatment regimen for PCV. The aim of this study is to compare the outcomes of different treatment methods including PDT, IVR and combination therapy under the 1+PRN treatment regimen for PCV. The study is the first prospective randomized controlled trial about different treatment methods on PCV under 1+PRN treatment regimen. The null hypothesis of the study is that combination therapy may be the optimal treatment method for PCV. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the optimal treatment for PCV.

Official Title
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Comparison of the Effects of Photodynamic Therapy, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen

Conditions
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Polypoidal Choroidal Vasculopathy

Intervention / Treatment
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* Drug: verteporfin
* Drug: verteporfin and ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: active macula-involved polypoidal lesions evidenced by ICGA; greatest linear dimension of 5400 μm or less assessed by ICGA; follow-up of at least 12 months. Exclusion Criteria: any other ocular disease, such as ocular trauma, glaucoma, uveitis, diabetic retinopathy, angioid streaks, pathologic myopia, or presumed ocular histoplasmosis syndrome; any systemic contraindication to the PDT, IVR, sodium fluorescein, or indocyanine green dyes; any severe uncontrolled systemic disease, such as uncontrolled hypertention, coronary heart disease, liver failure, or kidney failure.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: photodynamic therapy<br>Participants will be given the standard verteporfin photodynamic therapy at baseline followed by additional standard verteporfin PDT as needed (every three months)(namely 1+PRN regimen). | Drug: verteporfin<br>* Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.<br>* Other names: ranibizumab;Drug: verteporfin and ranibizumab<br>* Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.<br>|
| Experimental: intravitreal ranibizumab<br>Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab will be given to the participants when necessary (every month) (namely 1+PRN regimen). | Drug: verteporfin<br>* Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.<br>* Other names: ranibizumab;Drug: verteporfin and ranibizumab<br>* Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.<br>|
| Experimental: combination therapy of PDT and IVR<br>Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the standard verteporfin PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary (every month)(namely 1+PRN regimen). | Drug: verteporfin<br>* Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.<br>* Other names: ranibizumab;Drug: verteporfin and ranibizumab<br>* Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | the best corrected visual acuity is the Primary Outcome Measure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polypoidal choroidal vasculopathy, photodynamic therapy, ranibizumab, combination therapy, cost-benefit