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Objective: To confirm the reproducibility of the effectiveness and safety in photodynamic diagnosis of non-muscle-invasive bladder cancer using 5-aminolevulinic acid in a prospective multicenter non-randomized phase III trial., Methods: A total of 61 patients with primary or recurrent non-muscle-invasive bladder cancer were prospectively enrolled from five hospitals between May 2015 and March 2016. 5-Aminolevulinic acid (20 mg/kg) was orally administered 3 h before transurethral resection of bladder tumors using white light or fluorescent light. Of 60 evaluable patients, 511 specimens were obtained from tumor-suspicious lesions and normal-looking mucosa. The primary end-point was sensitivity. The secondary end-points were specificity, positive and negative predictive values, and safety., Results: The sensitivity of the fluorescent light source (79.6%) was significantly higher (P < 0.001) than that of the white light source (54.1%). In total, 25.4% (46/181) of tumor specimens were diagnosed as positive with only the fluorescent light source. In nine (15%) of 60 patients, the risk classification and recommended treatment after transurethral resection of bladder tumors were changed depending on the additional types of tumor diagnosed by the fluorescent light source. The specificity of the fluorescent light versus white light source was 80.6% versus 95.5%. No grade 4-5 adverse event was noted. Hypotension and urticaria were severe adverse events whose relationship to oral 5-aminolevulinic acid could not be excluded., Conclusions: These findings confirm the diagnostic efficacy and safety of photodynamic diagnosis with 20 mg/kg of oral 5-aminolevulinic acid, and show that transurethral resection of bladder tumors with a fluorescent light source using oral 5-aminolevulinic acid is well tolerated., (© 2018 The Japanese Urological Association.)

Objective: The purpose of this study is to investigate methods of evaluating therapeutic parameters used in the premarket evaluation of photodynamic therapy (PDT) drugs that have previously been approved in Japan and the United States, in order to establish a methodology that allows optimization of the therapeutic parameters of PDT, and to analyze current issues., Materials and Methods: We examined the details of premarket evaluation of drug dose, drug-light intervals, as well as wavelengths, power density, and energy density of illumination sources used for the PDT drugs that have been approved in Japan the United States., Results: There was a tendency for optimal drug dose and light energy density to be assessed in clinical studies. Drug-light intervals were assessed in the United States in clinical studies, and in Japan only in non-clinical studies. For various drugs, drug-light intervals were assessed based on fluorescence. For most drugs, the wavelength at which the drug can be photo-activated was determined in non-clinical studies. We found only few examples regarding the optimization of light power density as compared to the other therapeutic parameters., Conclusions: Drug dose, drug-light interval, and light energy density are particularly important parameters with regard to the efficacy and safety of PDT drugs. In order to determine the optimal therapeutic parameters of PDT more effectively, appropriate clinical studies need to be designed. Also the use of biomedical engineering, such as fluorescence measurement, is effective for optimizing PDT therapeutic parameters. We believe that in the future there will be a greater number of regulatory science related studies like ours will lead to the further spread of PDT., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Purpose: To determine the association of age-related maculopathy susceptibility 2 (ARMS2) gene polymorphisms with the phenotype of typical neovascular age-related macular degeneration (tAMD) and polypoidal choroidal vasculopathy (PCV) and the effects of photodynamic therapy (PDT)., Methods: The single nucleotide polymorphisms at rs10490924 (A69S) in ARMS2 of 68 tAMD and 119 PCV patients who underwent PDT were genotyped using the TaqMan assay. The baseline best corrected visual acuity (BCVA) and lesion size were compared among the three genotypes at rs10490924. A multivariate regression analysis was performed to evaluate the influence of the baseline BCVA, greatest linear dimension (GLD), and lesion phenotype (tAMD or PCV) on the association of rs10490924 with the BCVA 12 months after the first PDT., Results: The mean lesion size was significantly different among the GG, GT, and TT genotypes at rs10490924 in the PCV group, although no significant differences were detected in the tAMD group. PCV patients with a G allele had significantly better vision at 3 months after the initial PDT. tAMD patients with a TT genotype had significantly poorer vision at 12 months after the first PDT. In the multivariate regression analysis, the additive model of the G allele at rs10490924 was associated with a significantly better BCVA 12 months after the first PDT in tAMD and PCV patients., Conclusions: ARMS2 variants are likely associated with the phenotype and the effects of PDT in tAMD and PCV.