PURPOSE

To compare demographics, visual acuity (VA) and retinal morphology between those with, and without baseline submacular hemorrhage (SMH) for patients enrolled in the Inhibit VEGF in Age-related Choroidal Neovascularization trial (IVAN).

DESIGN

Secondary analyses of a randomized, controlled trial of image and clinical data.

METHODS

Setting; The IVAN trial collected data in 23 UK hospitals. Study population; IVAN study eyes (with untreated neovascular age-related macular degeneration at randomization) with at least 12 months of follow-up and adequate imaging. Intervention; Study eyes were randomly assigned between monthly ranibizumab, as-needed ranibizumab, monthly bevacizumab, or as-needed bevacizumab. Imaging at baseline was graded independently for the presence, type, position, and extent of SMH. Main outcome measures; The main outcome measures were VA (primary outcome), subretinal fibrosis, atrophic scarring, and retinal thickness outcomes at 12 and 24 months

RESULTS

Of 605 IVAN trial participants, 535 were included in this analysis. Patients with SMH at baseline (286 [53%]) were older (P = .010) and affected eyes were more likely to have intraretinal fluid present (P = .038). The VA was significantly worse in those with baseline SMH at month 0 (P < .001; estimate of difference 6 letters; 95% CIs, 4–8 letters), but the difference decreased and was not significant at month 12 or 24. No significant association was found between baseline SMH and subretinal fibrosis, atrophic scarring, or central retinal thickness.

CONCLUSIONS

The presence of SMH at baseline was associated with age, intraretinal fluid, and decreased baseline VA. By month 12, VA was no longer significantly different in those who presented with SMH at baseline.

中文翻译：

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IVAN 试验中年龄相关性黄斑变性继发黄斑下出血患者的关联和结局

目的

比较年龄相关脉络膜新生血管试验 (IVAN) 中参与抑制 VEGF 的患者的人口统计学、视力 (VA) 和视网膜形态。

设计

图像和临床数据的随机对照试验的二次分析。

方法

环境; IVAN 试验收集了 23 家英国医院的数据。研究人群；IVAN 研究眼睛（随机分组有未经治疗的新生血管性年龄相关性黄斑变性），至少 12 个月的随访和足够的成像。干涉; 研究眼在每月雷珠单抗、按需雷珠单抗、每月贝伐单抗或按需贝伐单抗之间随机分配。基线成像根据 SMH 的存在、类型、位置和范围独立分级。主要观察指标; 主要结果指标是 12 个月和 24 个月时的 VA（主要结果）、视网膜下纤维化、萎缩性瘢痕和视网膜厚度结果

结果

在 605 名 IVAN 试验参与者中，535 名被纳入该分析。基线时患有 SMH 的患者 (286 [53%]) 年龄较大 ( P  = .010)，受影响的眼睛更有可能存在视网膜内液体 ( P  = .038)。在第 0 个月具有基线 SMH 的患者的 VA 显着更差（P < .001；差异估计值 6 个字母；95% CI，4-8 个字母），但差异在第 12 个月或第 24 个月时下降且不显着。基线 SMH 与视网膜下纤维化、萎缩性瘢痕或视网膜中央厚度之间存在显着关联。

结论

基线时 SMH 的存在与年龄、视网膜内液体和基线 VA 降低有关。到第 12 个月，基线时出现 SMH 的患者的 VA 不再有显着差异。