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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
113
Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
Nagoya City University Hospital
Aichi, Japan
Nagoya University
Aichi, Japan
Kyushu University
Fukuoka, Japan
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.
Time frame: 12 months
Proportion of number of study eyes which BCVA improves 3 lines or more or maintains (+/-1 line), as compared with baseline examination.
Time frame: 12 month
Factor affecting to change in visual acuity.
Time frame: 12month
Proportion of eyes with decimal BCVA of 0.5 or more.
Time frame: 12 month
Change of findings of polypoidal lesions.
Time frame: 0-12 month
Change of findings of abnormal network vessels.
Time frame: 0-12 month
Change in greatest linear dimension (GLD) based on FA.
Time frame: 0-12 month
PCV lesion size based on ICGA.
Time frame: 0-12 month
Choroidal neovascularization (CNV) closure based on FA.
Time frame: 0-12 month
Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT).
Time frame: 0-12month
Mean number of PDT treatments required during the study period.
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Fukushima Medical University School of Medicine
Fukushima, Japan
Gunma University
Gunma, Japan
Kagawa University
Kagawa, Japan
Kyoto University
Kyoto, Japan
Osaka University
Osaka, Japan
Kansai Medical University Takii Hospital
Osaka, Japan
Kansai Medical University Hirakata Hospital
Osaka, Japan
...and 7 more locations
Time frame: 12 month