中国维替泊芬光动力疗法治疗年龄相关性黄斑变性中心凹下脉络膜新生血管的多中心临床研究

目的探讨以维替泊芬为光敏剂的光动力疗法（PDT）治疗年龄相关性黄斑变性（AMD）合并黄斑中心凹下典型脉络膜新生血管（CNV）的疗效和安全性。方法采用多中心、开放、非对照Ⅲ期临床试验。受试对象为黄斑中心凹下以典型CNV为主的AMD患者。观察期限为24周。于第1次治疗后12和24周末进行复查。在首次治疗后12周,如发现CNV复发,则重复进行光动力治疗。比较治疗前后眼底病灶及视力的改变。记录治疗及随诊中所有的不良反应。结果共有32例患者入选,符合选择标准的患者为31例（31只眼）。在24周的观察中,38．7％的治疗眼视力增加5个字母以上,视力提高或减少小于15个字母者占83．9％。首次治疗后12周,CNV完全无渗漏的为12．9％;有渗漏,但局限于原病灶区的为61．3％;渗漏有进展者为25．8％。首次治疗后24周,病灶和病灶周围萎缩区大小、整个病变区域的最大直线距离均比治疗前稍有扩大,但差异均无统计学意义（P=0．65,0．31,0．12）。由此表明,在治疗的24周中,患眼的病灶基本稳定,未见明显扩大。PDT治疗后未发现病灶瘢痕明显扩大。整个临床试验中,11例（34．4％）发生了不良事件,其中7例（21．9％）为轻度不良事件,3例（9．4％）为中度不良事件,1例（3．1％）为重度不良事件。PDT治疗后24周,血尿常规和心电图检查均未见明显异常。结论用维替泊芬为光敏剂的PDT治疗AMD患者黄斑中心凹下CNV有较好的疗效,可以减轻CNV的渗漏,延缓视力下降,而且与药物相关的不良事件发生率低。因此,以维替泊芬为光敏剂的PDT治疗AMD继发的典型CNV其疗效肯定且安全。

Clinical trial of verteporfin photodynamic therapy in Chinese age-related macular degeneration with subfoveal predominant choroidal neovascularization patients

OBJECTIVE: To determine the safety and efficacy of verteporfin (visudyne) photodynamic therapy in age-related macular degeneration patients with subfoveal predominant choroidal neovascularization in China. METHODS: Multicenter, open-label, non-controlled clinical study. The included patients are diagnosed AMD patients with predominant classic CNV. The included patients received verteporfin intravenously followed by 689 nm laser light administration 15 minutes after the infusion start. The patients were be followed up for 24 weeks (+/-12 days) after initial verteporfin PDT treatment. Clinical follow-up was done at the end of week 12 (+/-12 days) and week 24 (+/-12 days) after the initial treatment. Additional treatment was given after 12 weeks from initial treatment if leakage from CNV was observed on fundus fluorescein angiogram. The visual acuity with ETDRS visual chart and the retinal lesion changes were documented and compared with baseline. The adverse events both in the process of treatment and in the follow-up were recorded throughout the entire study period. RESULTS: Thirty-one patients (31 eyes) were included and completed the trial with vertepofin PDT treatment. During the 24 weeks of the trial, 38.7% of the treated eyes had a vision gain more than 5 letters, 83.9% of the treated eyes had less than 15 letters vision loss. At week 12 after the initial treatment, 12.9% of the treated eyes had no leakage; 61.3% of the treated eyes had leakages, but limited to the former lesion, 25.8% of the treated eyes had increased leakage. The results at week 24 after the initial treatment were similar to those at week 12. At week 24 after the initial treatment, there were only slight enlargements in the lesion size, area of retinal lesion, the lesion surrounding area, and greatest linear dimension (GLD) of the lesion, but no statistical significant difference was found between baseline and week 12 after initial treatment (P = 0.65, 0.31, 0.12, respectively). No obvious progress of the fibrosis was detected in most of the PDT treated eyes. Eleven cases of adverse events (AE) occurred in our trial and the incidence was 34.4%. Among the 11 patients with reported adverse event, 7 (21.9%) had mild adverse event; 3 (9.4%) had moderate adverse events; 1 (3.1%) had a serious adverse event. During the study period, no abnormal changes were found in most of the laboratory tests including serum and urine biochemistry, hematology and Electrocadiogram. CONCLUSIONS: The results of this trial showed positive efficacy of PDT with verteporfin in the treatment of predominantly subfoveal CNV secondary to AMD by reducing the risk of vision loss. The incidence of serious adverse events was only 3.1%. It is highly safe to use PDT with verteporfin in Chinese AMD patients with subfoveal predominant classical CNV.