Stein Eye Institute, University of California, Los Angeles, Los Angeles, California.
Sierra Eye Associates, Reno, Nevada.
Retina. 2024 Jan 1;44(1):10-19. doi: 10.1097/IAE.0000000000003935.
To evaluate the impact of pigment epithelial detachment (PED) thickness (i.e., height) and thickness variability on best-corrected visual acuity outcomes in patients with neovascular age-related macular degeneration in the Phase 3 HAWK and HARRIER trials.
Optical coherence tomography images from the pooled brolucizumab 6 mg and aflibercept 2 mg arms were analyzed for the maximum PED thickness across the macula at baseline through to week 96. Best-corrected visual acuity outcomes were compared in patients with different PED thickness and variability cut-off thresholds.
Greater PED thickness at baseline or at week 12 was associated with lower mean best-corrected visual acuity gain from baseline to week 96 (baseline PED ≥200 µ m: +4.6 letters; <200 µ m: +7.0 letters; week 12 PED ≥100 µ m: +5.6 letters; <100 µ m: +6.6 letters). Eyes with the largest PED thickness variability from week 12 through week 96 gained fewer letters from baseline at week 96 (≥33 µ m: +3.3 letters; <9 µ m: +6.2 letters). Furthermore, increased PED thickness at week 48 was associated with higher prevalence of intraretinal and subretinal fluid.
In this treatment-agnostic analysis, greater PED thickness and PED thickness variability were associated with poorer visual outcomes in patients with neovascular age-related macular degeneration and greater neovascular activity.
评估在 3 期 HAWK 和 HARRIER 试验中,色素上皮脱离(PED)厚度(即高度)和厚度变异性对新生血管性年龄相关性黄斑变性患者最佳矫正视力结局的影响。
对 pooled brolucizumab 6 mg 和 aflibercept 2 mg 臂的光学相干断层扫描图像进行分析,以确定基线至第 96 周时黄斑区最大 PED 厚度。根据不同的 PED 厚度和变异性截断阈值比较最佳矫正视力结局。
基线或第 12 周时更大的 PED 厚度与从基线到第 96 周的平均最佳矫正视力增益降低相关(基线 PED ≥200 µm:+4.6 个字母;<200 µm:+7.0 个字母;第 12 周 PED ≥100 µm:+5.6 个字母;<100 µm:+6.6 个字母)。从第 12 周到第 96 周 PED 厚度变化最大的眼睛从基线到第 96 周获得的字母数较少(≥33 µm:+3.3 个字母;<9 µm:+6.2 个字母)。此外,第 48 周时 PED 厚度增加与视网膜内和视网膜下液的患病率增加有关。
在这种治疗无差异分析中,更大的 PED 厚度和 PED 厚度变异性与新生血管性年龄相关性黄斑变性患者视力结局较差和新生血管活动增加有关。