PURPOSE To better characterize visual function decline and geographic atrophy (GA) progression secondary to age-related macular degeneration (AMD). DESIGN Proxima A (NCT02479386)/Proxima B (NCT02399072) were global, prospective, noninterventional, observational clinical trials. PARTICIPANTS Eligible patients were aged ≥50 years. Patients in Proxima A had bilateral GA without choroidal neovascularization (CNV) in either eye (N = 295). Patients in Proxima B had GA without CNV in the study eye and CNV±GA in the fellow eye (fellow eye CNV cohort, n = 168) or GA without CNV in the study eye, no CNV/GA in the fellow eye (fellow eye intermediate AMD cohort, n = 32). METHODS Changes in visual function and imaging/anatomic parameters were evaluated over time using a mixed model for repeated measurement accounting for key baseline characteristics. MAIN OUTCOME MEASURES Prespecified end points included change in GA area from baseline, best-corrected visual acuity (BCVA) score assessed by Early Treatment Diabetic Retinopathy Study (ETDRS), and visual acuity under low-luminance (LLVA). RESULTS At 24 months, adjusted mean (standard error) change in GA lesion area from baseline was 3.87 (0.15) mm2 in participants with bilateral GA (Proxima A), 3.55 (0.16) mm2 in the fellow eye CNV cohort (Proxima B), and 2.96 (0.25) mm2 in the fellow eye intermediate AMD cohort (Proxima B). Progression of GA was greater in patients with baseline nonsubfoveal (vs. subfoveal) GA lesions and tended to increase as baseline low-luminance deficit increased (all patients). Conversion to GA or CNV in the fellow eye occurred in 30% and 6.7% of participants, respectively, in the Proxima B intermediate AMD cohort at month 12. Adjusted mean (standard error) changes in BCVA and LLVA (ETDRS letters) in the study eye from baseline to 24 months were -13.88 (1.40) and -7.64 (1.20) in Proxima A, -9.49 (1.29) and -7.57 (1.26) in Proxima B fellow eye CNV cohort, and -11.48 (3.39) and -8.37 (3.02) in Proxima B fellow eye intermediate AMD cohort, respectively. CONCLUSIONS The prospective Proxima A and B studies highlight the severe functional impact of GA and the rapid rate of GA lesion progression over a 2-year period, including in patients with unilateral GA at baseline.

中文翻译：

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继发于年龄相关性黄斑变性的地理萎缩的自然史：前瞻性Proxima A和B临床试验的结果。

目的为了更好地表征继发于年龄相关性黄斑变性（AMD）的视觉功能下降和地理萎缩（GA）进展。设计Proxima A（NCT02479386）/ Proxima B（NCT02399072）是全球性，前瞻性，非干预性的观察性临床试验。对象符合条件的患者年龄≥50岁。Proxima A的患者双眼GA均在两只眼睛中没有脉络膜新生血管（CNV）（N = 295）。Proxima B的患者在研究眼中患有CNV，而在另一只眼中患有CNV±GA（后眼CNV队列，n = 168），或者在研究眼中患有CNV / GA而在另一只眼中则没有CNV / GA（后眼）中级AMD队列，n = 32）。方法使用混合模型对视觉功能和影像学/解剖学参数随时间的变化进行评估，以便对主要基线特征进行重复测量。主要观察指标预先设定的终点包括与基线相比GA面积的变化，通过早期糖尿病性视网膜病变研究（ETDRS）评估的最佳矫正视敏度（BCVA）评分以及低照度下的视敏度（LLVA）。结果在24个月时，双侧GA（Proxima A）参与者的GA病变区域相对于基线的校正平均（标准误）变化为3.87（0.15）mm2，在同眼CNV队列（Proxima B）中为3.55（0.16）mm2，在另一只眼的中间AMD队列（Proxima B）中为2.96（0.25）mm2。具有基线非中央凹（相对于中央凹）GA病变的患者，GA的进展更大，并且随着基线低亮度不足的增加而增加（所有患者）。在另一只眼中，分别有30％和6.7％的人转换为GA或CNV。在Proxima B中间AMD队列中，在第12个月时的研究。从基线到24个月，研究眼中BCVA和LLVA（ETDRS字母）的校正平均值（标准误）变化在Proxima A中为-13.88（1.40）和-7.64（1.20） ，在Proxima B同类眼CNV队列中分别为-9.49（1.29）和-7.57（1.26），在Proxima B同类眼中间AMD队列中分别为-11.48（3.39）和-8.37（3.02）。结论前瞻性Proxima A和B研究强调了GA的严重功能影响以及2年内GA病变进展的快速速度，包括基线时单侧GA的患者。39）和-8.37（3.02）分别在Proxima B同伴眼中间AMD队列中。结论前瞻性Proxima A和B研究强调了GA的严重功能影响以及2年内GA病变进展的快速速度，包括基线时单侧GA的患者。39）和-8.37（3.02）分别在Proxima B同伴眼中间AMD队列中。结论前瞻性Proxima A和B研究强调了GA的严重功能影响以及2年内GA病变进展的快速速度，包括基线时单侧GA的患者。