PDT Study for Exudative AMD With PCV

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and conduct an exploratory comparison of the efficacy and safety of indocyanine green angiography (ICGA) guided photodynamic therapy (PDT) and fluorescein angiography (FA) guided PDT for exudative age-related macular degeneration (AMD) accompanied with polypoidal choroidal vasculopathy (PCV).

Detailed Description
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PDT with verteporfin has been proven beneficial for patients with AMD. The laser spot size is decided based on FA finding (FA guided PDT). ICGA is needed to detect PCV lesions, such as polypoidal lesions or abnormal network vessels. In clinical practice, PDT based on ICGA (ICGA guided PDT) has and is being conducted for the treatment of AMD with PCV. However, there are no reports on the outcomes of prospective research of PDT for PCV in Japanese patients. Furthermore, there are no reports comparing FA guided PDT and ICGA guided PDT. We propose to conduct this clinical research in order to investigate the efficacy and safety of PDT for PCV in Japanese patients, and to compare results of FA guided PDT and ICGA guided PDT.

Official Title
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Clinical Research of Photodynamic Therapy for Exudative Age-related Macular Degeneration Accompanied With Polypoidal Choroidal Vasculopathy

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Procedure: Ocular photodynamic therapy with verteporfin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese patients aged 50 years old or older Exudative AMD with subfoveal PCV Eyes with PCV meets the definite criteria of PCV issued from Japanese study group of Polypoidal Choroidal Vasculopathy PCV lesion with subfoveal hemorrhage or exudation Lesion size (GLD) of less than 12 MPS Disc area measured by FA and IA. Decimal BCVA of 0.1-0.5 at baseline period. Exclusion Criteria: Patients who have RPE tear, vitelliform retinal dystrophy, and central Serous Chorioretinopathy. Patients who have other ocular disease with irreversible VA Study eyes unable to be taken fundus photos of CNV Study eyes received surgery operation within 2 months of the participation to this study or ND:YAG operation within one month Pathological myopia PCV with cleary identified subsensory retinal CNV (on the RPE) at the baseline examination Study eyes which have received any treatments for CNV, such as PDT, transpupillary thermotherapy, laser photocoagulation, and so on. Patients who have any physical problem for using angiography or PDT (such as systemic debility, significant diabetes mellitus, significant heart disease, and so on) Medical history of porphyria, porphyrin sensitivity, or hypersensitivity to sunlight or bright light. Patients with medical history of hypersensitivity to ingredients of Visudyne Patients with medical history of hypersensitivity to ingredients of fluorescein or indocyanine green injection Patients with hypersensitivity to iodine Patients judged inappropriate for this study by the investigator

Ages Eligible for Study
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Minimum Age: 50 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>FA-guided PDT | Procedure: Ocular photodynamic therapy with verteporfin<br>* Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds<br>* Other names: photodynamic therapy;|
| Experimental: 2<br>ICG-guided PDT | Procedure: Ocular photodynamic therapy with verteporfin<br>* Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds<br>* Other names: photodynamic therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of study eyes which best corrected visual acuity (BCVA) improves 2 lines or more or maintains (+/-1 line changes) at 12 months after first treatment, as compared with the visual acuity at baseline period. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of number of study eyes which BCVA improves 3 lines or more or maintains (+/-1 line), as compared with baseline examination. |  | 12 month | 
| Factor affecting to change in visual acuity. |  | 12month | 
| Proportion of eyes with decimal BCVA of 0.5 or more. |  | 12 month | 
| Change of findings of polypoidal lesions. |  | 0-12 month | 
| Change of findings of abnormal network vessels. |  | 0-12 month | 
| Change in greatest linear dimension (GLD) based on FA. |  | 0-12 month | 
| PCV lesion size based on ICGA. |  | 0-12 month | 
| Choroidal neovascularization (CNV) closure based on FA. |  | 0-12 month | 
| Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT). |  | 0-12month | 
| Mean number of PDT treatments required during the study period. |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, PCV, PDT