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11-11-2002 22:36:26 阅读
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光动力（维速达尔）疗法治疗年龄相关性黄斑变性中央凹下脉络膜新生血管膜（CNV）：2个随机临床试验延续观察到3年结果 －光动力疗法治疗年龄相关性黄斑变性研究组报告之5
Blumenkranz MS, Bressler NM, Bressler SB, Donati G, Fish GE, Haynes LA, Lewis H, Miller JW, Mones JM, Potter MJ, Pournaras C, Reaves A, Rosenfeld PJ, Schachat AP, Schmidt-Erfurth U, Sickenburg M, Singerman LJ, Slakter JS, Strong A, Vannier S; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group.
Arch Ophthalmol 2002 Oct;120(10):1307-14
目的：报告一个2年期的湿性年龄相关性黄斑变性维速达尔光动力疗法的后续视力和安全性结果。
研究设计及安排：从2个多中心（22个北美和欧洲眼科诊所）、双盲、安慰剂对照的维速达尔光动力疗法治疗湿性年龄相关性黄斑变性的随机临床试验（TAP）中选择患者进行后续延长的观察。 对象：在TAP研究中随诊24个月，维速达尔治疗CNV可能减轻进一步视力丧失的危险的患者
方法：在延续期中接受维速达尔治疗前，入选的患者签署一份书面的知情同意书，这份知情同意书得到了当地研究机构的伦理委员会的口头同意。治疗方法同第一和第二年结果报告中描述的那样，2年后延续观察中除个别患者外均是每3个月随诊检查一次，这包括了如果在延续期内CNV荧光造影有渗漏将得到进一步的维速达尔治疗而不考虑其最初的治疗方案（试验组或对照组）。
结果：维速达尔治疗研究中共402个患者，其中351（87.3%）完成了24个月的观察，320名患者进入了延续期观察。这些患者中包括维速达尔治疗组中最初有明显经典型CNV159例患者中的124人（78.0%），在他们中间105人（84.7%）完成了36个月的随诊观察。在维速达尔治疗组中最初有这种病损的患者其中参加了延续期研究的人，不管他们是否完成了第36个月的随诊，他们都比那些没有参加延续期研究的人相对年轻、视力好、典型CNV没有渗漏或者在24个中病变进展不容易超过最初的界限。这105个最初即有典型黄斑病损并完成了36个月随诊的患者中从24－36个月（不包括第36个月）中平均治疗了1.3次。治疗眼与基线值相比视力得分至少下降15点的患者中，24个月随诊时占37.5%（39人），36个月随诊时占41.9%（41人）。在这些眼中视力下降在24个月（平均下降1.9行）和36个月（平均下降2.0行)相比差别很小。
从24～36月观察中，维速达尔治疗的患者平均视力下降变化不大，延续期治疗中很少或者没有注射渗漏导致的疼痛，或者光敏反应。2例最初在安慰剂组的患者在延续期中采用维速达尔治疗后7天内出现急性的严重视力下降，1例最初在治疗组的患者在延续期中治疗对侧眼后出现的急性的严重视力下降。
结论：虽然只有最初用维速达尔治疗具有这种病损患者的三分之一的人随诊了36个月，但最初有典型CNV的患者用维速达尔治疗之后在24－36个月中视力相对稳定。从这些结果看来，TAP研究小组没有发现用维速达尔重复治疗相关的安全性问题。进一步治疗是为了减少视力持续丧失的危险。因为在延续期观察中没有设立未治疗的对照组，而且并非所有的TAP研究的患者进入了延续期观察，因此我们应该小心地分析理解这些结果。
Verteporfin therapy for subfoveal choroidal neovascularization in age-related macular degeneration: three-year results of an open-label extension of 2 randomized clinical trials--TAP Report no. 5.
Blumenkranz MS, Bressler NM, Bressler SB, Donati G, Fish GE, Haynes LA, Lewis H, Miller JW, Mones JM, Potter MJ, Pournaras C, Reaves A, Rosenfeld PJ, Schachat AP, Schmidt-Erfurth U, Sickenburg M, Singerman LJ, Slakter JS, Strong A, Vannier S; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group.
OBJECTIVE: To report vision and safety outcomes from an extension of a 2-year investigation evaluating verteporfin photodynamic therapy in patients with age-related macular degeneration with subfoveal choroidal neovascularization (CNV). DESIGN AND SETTING: Open-label extension of selected patients from 2 multicenter, double-masked, placebo-controlled, randomized clinical trials, the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Investigation, at 22 ophthalmology practices in Europe and North America. PARTICIPANTS: Patients enrolled in the TAP Investigation and followed up for at least 24 months in whom verteporfin therapy to CNV might reduce the risk of further vision loss.
METHODS: Before receiving verteporfin therapy in the extension, eligible patients signed a written informed consent form accompanied by an oral consent process approved by local institutional review boards. Methods were similar to those described for 1- and 2-year results, with follow-up examinations beyond 2 years continuing at 3-month intervals with a few exceptions, including that extension patients with fluorescein leakage from CNV were to receive open-label verteporfin therapy irrespective of their original treatment assignment.
RESULTS: Of 402 patients in the verteporfin group, 351 (87.3%) completed the month 24 examination; 320 (91.2%) of these enrolled in the extension study. The enrolled participants included 124 (78.0%) of the 159 verteporfin-treated patients with lesions composed of predominantly classic CNV at baseline, of whom 105 (84.7%) completed the month 36 examination. Verteporfin-treated patients with this lesion composition at baseline who participated in the extension study, with or without a month 36 examination, appeared more likely to have a younger age, better level of visual acuity, absence of fluorescein leakage from classic CNV, or no progression of classic CNV beyond the baseline boundaries of the lesion at the month 24 examination compared with those who did not enroll in the extension. For the 105 patients with a predominantly classic baseline lesion composition who completed the month 36 examination, an average of 1.3 treatments were given from the month 24 examination up to, but not including, the month 36 examination. A letter score loss in the study eye of at least 15 from baseline for these patients occurred in 39 (37.5%) at the month 24 examination compared with 44 (41.9%) of these patients at the month 36 examination. Visual acuity changed little from the month 24 examination (mean, -1.9 lines) to the month 36 examination (mean, -2.0 lines) for these eyes. Verteporfin-treated patients had little change in the mean visual acuity lost and few or no additional instances of infusion-related back pain or photosensitivity reactions from month 24 to month 36. Two patients originally assigned to placebo had acute severe vision decrease within 7 days after verteporfin treatment during the extension. One patient originally assigned to verteporfin had acute severe vision decrease after verteporfin treatment of the fellow eye during the extension.
CONCLUSIONS: Vision outcomes for verteporfin-treated patients with predominantly classic lesions at baseline remained relatively stable from month 24 to month 36, although only approximately one third of the verteporfin-treated patients originally enrolled with this lesion composition had a month 36 examination. From these results, the TAP Study Group identified no safety concerns to preclude repeating photodynamic therapy with verteporfin. Additional treatment was judged likely to reduce the risk of further vision loss. Caution appears warranted in the absence of comparison with an untreated group during the extension and since not all patients in the TAP Investigation participated in the TAP Extension.
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