Barbazetto Irene, Burdan Amy, Bressler Neil M, Bressler Susan B, Haynes Laurie, Kapetanios Anastasios D, Lukas Julius, Olsen Karl, Potter Michael, Reaves Al, Rosenfeld Philip, Schachat Andrew P, Strong H Andrew, Wenkstern Andrea
Medizinische Universität zu Lübeck, Klinik für Augenheilkunde, Lübeck, Germany.
Arch Ophthalmol. 2003 Sep;121(9):1253-68. doi: 10.1001/archopht.121.9.1253.
To describe fluorescein angiographic guidelines for the use of verteporfin therapy in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or other conditions based on 2-year vision outcomes from the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Investigation and Verteporfin in Photodynamic Therapy (VIP) Trial.
Three multicenter, double-masked, placebo-controlled randomized clinical trials at 28 ophthalmology clinical centers in Europe and North America involving prospectively identified patients with best-corrected visual acuity (Snellen equivalent) of approximately 20/20 to 20/200, subfoveal CNV secondary to AMD or pathologic myopia with evidence of CNV, and a lesion greatest linear dimension of 5400 micro m or less. Fluorescein angiography was to be performed on all patients at enrollment and at regular 3-month follow-up visits through 2 years. The initial treatment laser spot size and all subsequent treatment decisions were based on the investigator's interpretation of these fluorescein angiograms. Photographic materials forwarded to the Wilmer Photograph Reading Center were reviewed by masked graders.
Baseline angiographic features, including lesion composition and size, morphologic response to treatment during follow-up (eg, absence of leakage), and reliability (kappa values) of grading selected characteristics based on a 10% regrading of baseline visits.
Terms and examples of different lesions and lesion components are provided to assist recognition of fluorescein angiographic characteristics of choroidal neovascular lesions that were important in determining when and where to apply verteporfin therapy. The kappa statistics for agreement of identification of lesion characteristics by the Wilmer Photograph Reading Center for these trials ranged from 0.70 to 0.85.
Ophthalmologists should consider interpreting fluorescein angiographic images of subfoveal lesions with terms provided to follow recommendations regarding which patients are most likely to benefit from verteporfin therapy based on results from the TAP Investigation and VIP Trial.
根据年龄相关性黄斑变性（AMD）光动力疗法（TAP）研究和维替泊芬光动力疗法（VIP）试验的2年视力结果，描述在年龄相关性黄斑变性（AMD）或其他疾病继发的中心凹下脉络膜新生血管（CNV）患者中使用维替泊芬治疗的荧光素血管造影指南。
在欧洲和北美的28个眼科临床中心进行了三项多中心、双盲、安慰剂对照的随机临床试验，纳入了前瞻性确定的最佳矫正视力（Snellen等效视力）约为20/20至20/200、AMD或病理性近视继发中心凹下CNV且有CNV证据、病变最大线性尺寸为5400微米或更小的患者。所有患者在入组时以及在长达2年的定期3个月随访中均需进行荧光素血管造影。初始治疗激光光斑大小及所有后续治疗决策均基于研究者对这些荧光素血管造影的解读。转送至威尔默摄影阅读中心的摄影材料由盲法分级者进行评估。
基线血管造影特征，包括病变组成和大小、随访期间对治疗的形态学反应（如无渗漏），以及基于对基线访视10%的重新分级对选定特征进行分级的可靠性（kappa值）。
提供了不同病变和病变成分的术语及示例，以帮助识别脉络膜新生血管病变的荧光素血管造影特征，这些特征对于确定何时何地应用维替泊芬治疗很重要。这些试验中威尔默摄影阅读中心对病变特征识别的一致性kappa统计值范围为从0.70至0.85。
眼科医生应考虑根据TAP研究和VIP试验的结果，使用所提供的术语来解读中心凹下病变的荧光素血管造影图像，以遵循关于哪些患者最可能从维替泊芬治疗中获益的建议。
