外网状层管腔化可预测年龄相关性黄斑变性中地图样萎缩的扩大量。

Outer retinal tubulation as a predictor of the enlargement amount of geographic atrophy in age-related macular degeneration.

机构信息

Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, California.

出版信息

Ophthalmology. 2015 Feb;122(2):407-13. doi: 10.1016/j.ophtha.2014.08.035. Epub 2014 Oct 12.

DOI:10.1016/j.ophtha.2014.08.035

PMID:25315664

Abstract

PURPOSE

To determine the prognostic value of outer retinal tubulation (ORT) in the enlargement amount of geographic atrophy (GA) in eyes with age-related macular degeneration (AMD).

DESIGN

Cohort study.

PARTICIPANTS

One hundred eight fellow untreated eyes of 143 patients with GA resulting from AMD enrolled in the MAHALO study (clinicaltrials.gov identifier, NCT01229215) who completely satisfied the study term and had gradable spectral-domain optical coherence tomography (OCT) images obtained at both baseline and month 18 visits.

METHODS

The MAHALO study enrolled 143 subjects into a phase 1b/2 multicenter, randomized, single-masked, sham-injection controlled clinical trial of the safety, tolerability, and evidence of activity of lampalizumab in patients with GA associated with AMD. Spectral-domain optical coherence tomography images were obtained at multiple time points in both eyes, although only the baseline and month 18 data of the fellow (nonstudy) eyes were considered in this exploratory analysis. The Cirrus HD-OCT review software was used for automatic segmentation and measurement of GA areas, with manual correction of segmentation errors by certified OCT graders. Baseline OCT images also were assessed for the presence of ORT. The enlargement amount of GA in eyes with ORT was compared with that of eyes without ORT.

MAIN OUTCOME MEASURES

Comparison of the enlargement amount of GA in eyes with and without ORT.

RESULTS

Twenty-four of these 108 eyes demonstrated evidence of ORT. The amount of enlargement of GA in eyes with ORT was significantly slower than that of eyes without ORT (1.85±0.78 vs. 2.67±1.61; P = 0.001). This difference remained significant when considering subgroups with unifocal or multifocal GA lesions, because eyes with ORT in both subgroups had a slower enlargement amount of GA than eyes without ORT (2.91±1.70 vs. 2.08±0.88 [P = 0.01], in eyes with multifocal GA lesions; and 2.24±1.40 vs. 1.63±0.57 [P = 0.02], in eyes with unifocal GA lesions).

CONCLUSIONS

In eyes with ORT, GA lesions seem to enlarge at a significantly slower rate than those of eyes without ORT. The presence of ORT may need to be accounted for in longitudinal studies of GA.

摘要

目的

确定外层视网膜管腔（ORT）在年龄相关性黄斑变性（AMD）患者中与地理萎缩（GA）扩大量相关的预后价值。

设计

队列研究。

参与者

纳入 MAHALO 研究（clinicaltrials.gov 标识符，NCT01229215）中 143 名 GA 患者的 108 只未经治疗的同胞眼，这些患者的 GA 是由 AMD 引起的，完全满足研究期限，并在基线和第 18 个月就诊时获得可分级的谱域光学相干断层扫描（OCT）图像。

方法

MAHALO 研究纳入 143 名患者进行了 1b/2 期、多中心、随机、单盲、假注射对照临床试验，以评估 lampalizumab 在与 AMD 相关的 GA 患者中的安全性、耐受性和活性证据。尽管仅对同胞（非研究）眼的基线和第 18 个月的数据进行了这项探索性分析，但在两只眼中都获得了谱域 OCT 图像。使用 Cirrus HD-OCT 复查软件进行 GA 区域的自动分割和测量，并由经过认证的 OCT 分级员手动校正分割错误。在基线 OCT 图像上评估是否存在 ORT。比较有和无 ORT 的 GA 扩大量。

主要观察指标

比较有和无 ORT 的 GA 扩大量。

结果

这 108 只眼中有 24 只显示出 ORT 的证据。ORT 眼的 GA 扩大量明显慢于无 ORT 眼（1.85±0.78 与 2.67±1.61；P=0.001）。当考虑具有单灶或多灶 GA 病变的亚组时，这种差异仍然显著，因为这两个亚组的 ORT 眼的 GA 扩大量均比无 ORT 眼慢（2.91±1.70 与 2.08±0.88[P=0.01]，多灶 GA 病变眼；2.24±1.40 与 1.63±0.57[P=0.02]，单灶 GA 病变眼）。