Department of Ophthalmology, University of Bonn, Bonn, Germany; GRADE Reading Center, University of Bonn, Bonn, Germany.
Université Pierre et Marie Curie and Institut de la Vision, Paris, France.
Ophthalmology. 2016 Feb;123(2):361-368. doi: 10.1016/j.ophtha.2015.09.036. Epub 2015 Nov 3.
The Geographic Atrophy Progression (GAP) study was designed to assess the rate of geographic atrophy (GA) progression and to identify prognostic factors by measuring the enlargement of the atrophic lesions using fundus autofluorescence (FAF) and color fundus photography (CFP).
Prospective, multicenter, noninterventional natural history study.
A total of 603 participants were enrolled in the study; 413 of those had gradable lesion data from FAF or CFP, and 321 had gradable lesion data from both FAF and CFP.
Atrophic lesion areas were measured by FAF and CFP to assess lesion progression over time. Lesion size assessments and best-corrected visual acuity (BCVA) were conducted at screening/baseline (day 0) and at 3 follow-up visits: month 6, month 12, and month 18 (or early exit).
The GA lesion progression rate in disease subgroups and mean change from baseline visual acuity.
Mean (standard error) lesion size changes from baseline, determined by FAF and CFP, respectively, were 0.88 (0.1) and 0.78 (0.1) mm(2) at 6 months, 1.85 (0.1) and 1.57 (0.1) mm(2) at 12 months, and 3.14 (0.4) and 3.17 (0.5) mm(2) at 18 months. The mean change in lesion size from baseline to month 12 was significantly greater in participants who had eyes with multifocal atrophic spots compared with those with unifocal spots (P < 0.001) and those with extrafoveal lesions compared with those with foveal lesions (P = 0.001). The mean (standard deviation) decrease in visual acuity was 6.2 ± 15.6 letters for patients with image data available. Atrophic lesions with a diffuse (mean 0.95 mm(2)) or banded (mean 1.01 mm(2)) FAF pattern grew more rapidly by month 6 compared with those with the "none" (mean, 0.13 mm(2)) and focal (mean, 0.36 mm(2)) FAF patterns.
Although differences were observed in mean lesion size measurements using FAF imaging compared with CFP, the measurements were highly correlated with one another. Significant differences were found in lesion progression rates in participants stratified by hyperfluorescence pattern subtype. This large GA natural history study provides a strong foundation for future clinical trials.
GAP 研究旨在通过眼底自发荧光（FAF）和彩色眼底照相（CFP）测量萎缩病变的扩大，评估地理萎缩（GA）的进展速度，并确定预后因素。
前瞻性、多中心、非干预性自然史研究。
共有 603 名参与者参加了这项研究；其中 413 名有可分级的病变数据来自 FAF 或 CFP，321 名有可分级的病变数据来自 FAF 和 CFP。
通过 FAF 和 CFP 测量萎缩病变面积，以评估随时间推移的病变进展情况。病变大小评估和最佳矫正视力（BCVA）在筛查/基线（第 0 天）和 3 次随访时进行：第 6 个月、第 12 个月和第 18 个月（或提前退出）。
疾病亚组中的 GA 病变进展率和基线视力的平均变化。
FAF 和 CFP 分别确定的基线时病变大小的平均（标准误差）变化为：6 个月时为 0.88（0.1）和 0.78（0.1）mm2；12 个月时为 1.85（0.1）和 1.57（0.1）mm2；18 个月时为 3.14（0.4）和 3.17（0.5）mm2。与单病灶相比，多灶性萎缩斑患者（P < 0.001）和盘外病变患者（P=0.001）的病变大小从基线到 12 个月的平均变化明显更大。对于有图像数据的患者，视力的平均（标准差）下降为 6.2±15.6 个字母。与“无”（平均 0.13mm2）和局灶性（平均 0.36mm2）FAF 模式相比，弥漫性（平均 0.95mm2）或带状（平均 1.01mm2）FAF 模式的萎缩病变在 6 个月时生长速度更快。
尽管 FAF 成像测量的平均病变大小与 CFP 相比存在差异，但彼此之间高度相关。根据高荧光模式亚型对参与者进行分层，发现病变进展率存在显著差异。这项大型 GA 自然史研究为未来的临床试验提供了坚实的基础。
