Blinder Keven J, Bradley Shannon, Bressler Neil M, Bressler Susan B, Donati Guy, Hao Yong, Ma Colin, Menchini Ugo, Miller Joan, Potter Michael J, Pournaras Constantin, Reaves Al, Rosenfeld Philip J, Strong H Andrew, Stur Michael, Su Xiang Yao, Virgili Gianni
Am J Ophthalmol. 2003 Sep;136(3):407-18. doi: 10.1016/s0002-9394(03)00223-x.
To determine whether differences in baseline lesion size and visual acuity might explain differing results found in three different lesion compositions (predominantly classic, minimally classic, and occult with no classic) among three placebo-controlled, randomized clinical trials evaluating photodynamic therapy with verteporfin (Visudyne, Novartis AG), also termed verteporfin therapy, in patients with subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
Exploratory analyses were conducted in patients with predominantly classic or minimally classic lesions at enrollment in the Treatment of AMD with Photodynamic Therapy (TAP) Investigation and in AMD patients with occult with no classic CNV in the Verteporfin In Photodynamic Therapy (VIP) Trial. Baseline characteristics of patients among these three lesion compositions were compared. In addition, multiple linear regression modeling was used to explore the effect of baseline lesion size, visual acuity, and lesion composition on mean change in visual acuity from baseline to 24 months.
At baseline, the mean size of predominantly classic lesions (3.4 disk areas) was smaller than that of minimally classic (4.7 disk areas) and occult with no classic lesions (4.3 disk areas). In the multiple linear regression model of individual lesion compositions, there was a significant treatment-by-lesion-size interaction for minimally classic and occult with no classic lesions, but not for predominantly classic lesions. Interaction between treatment and baseline visual acuity was not significant for any lesion composition. Small verteporfin-treated lesions lost less vision than large verteporfin-treated lesions in each lesion composition. In the multiple linear regression model that included all lesion compositions, lesion size was a more significant predictive factor for the magnitude of treatment benefit than either lesion composition or visual acuity. Smaller (4.0 disk areas or less) minimally classic and occult with no classic lesions had similar visual acuity outcomes to those observed in predominantly classic lesions.
Based on exploratory analyses, lesion size in the TAP Investigation and VIP Trial was an important predictor of the magnitude of treatment benefit with verteporfin therapy in occult with no classic and minimally classic lesion compositions. In patients with AMD, treating smaller rather than larger neovascular lesions, regardless of lesion composition, likely will result in a better level of visual acuity.
在三项安慰剂对照的随机临床试验中，评估维替泊芬（Visudyne，诺华公司）光动力疗法（也称为维替泊芬治疗）对年龄相关性黄斑变性（AMD）所致中心凹下脉络膜新生血管（CNV）患者的疗效，以确定基线病变大小和视力差异是否可以解释三种不同病变构成（主要为典型性、微小典型性、隐匿性且无典型性）所得到的不同结果。
在光动力疗法治疗AMD（TAP）研究中，对入组时主要为典型性或微小典型性病变的患者，以及在维替泊芬光动力疗法（VIP）试验中隐匿性且无典型CNV的AMD患者进行探索性分析。比较这三种病变构成患者的基线特征。此外，使用多元线性回归模型探讨基线病变大小、视力和病变构成对从基线到24个月视力平均变化的影响。
基线时，主要为典型性病变的平均大小（3.4个视盘面积）小于微小典型性病变（4.7个视盘面积）和隐匿性且无典型性病变（4.3个视盘面积）。在各病变构成的个体多元线性回归模型中，微小典型性和隐匿性且无典型性病变存在显著的治疗与病变大小交互作用，但主要为典型性病变不存在。治疗与基线视力之间的交互作用在任何病变构成中均不显著。在每种病变构成中，接受维替泊芬治疗的小病变视力丧失比大病变少。在包含所有病变构成的多元线性回归模型中，病变大小比病变构成或视力对治疗益处程度的预测更显著。较小（4.0个视盘面积或更小）的微小典型性和隐匿性且无典型性病变的视力结果与主要为典型性病变的相似。
基于探索性分析，TAP研究和VIP试验中的病变大小是维替泊芬治疗隐匿性且无典型性和微小典型性病变构成时治疗益处程度的重要预测指标。对于AMD患者，无论病变构成如何，治疗较小而非较大的新生血管病变可能会获得更好的视力水平。
