Retina Service, Wills Eye Hospital, Mid Atlantic Retina, Thomas Jefferson University, Philadelphia, Pennsylvania.
JAMA Ophthalmol. 2016 Apr;134(4):437-43. doi: 10.1001/jamaophthalmol.2016.0045.
There is a subset of eyes with neovascular age-related macular degeneration (AMD) that have persistent exudation despite fixed-interval intravitreous anti-vascular endothelial growth factor (VEGF) injections.
To evaluate the effect of topical dorzolamide hydrochloride-timolol maleate on anatomic and functional outcomes in eyes with neovascular AMD and incomplete response to anti-VEGF therapy.
DESIGN, SETTING, AND PARTICIPANTS: An exploratory, prospective single-arm interventional study at a tertiary referral academic private practice. Patients with neovascular AMD and persistent macular edema despite fixed-interval intravitreous anti-VEGF therapy were enrolled. Baseline spectral-domain optical coherence tomography and clinical data, including visual acuity and intraocular pressure, were obtained at enrollment and from one visit before enrollment. The study was performed at the Retina Service of Wills Eye Hospital and the offices of Mid Atlantic Retina from February 1, 2015, through September 30, 2015. Patients were followed up for at least 2 visits after enrollment. Central subfield thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height from spectral-domain optical coherence tomography were recorded at each visit.
Enrolled eyes received a regimen of topical dorzolamide-timolol twice daily and continued to receive the same intravitreous anti-VEGF therapy at the same interval as received before enrollment for the duration of the study.
Change in central subfield thickness was the primary outcome measure. Changes in maximum subretinal fluid height, maximum pigment epithelial detachment height, and visual acuity were the secondary outcome measures.
Ten patients (10 eyes) completed the study. The mean age of the patients was 78.2 years (age range, 65-91 years), and 6 were male. Eight eyes received intravitreous aflibercept, and 2 eyes received intravitreous ranibizumab. All study eyes had been receiving long-term anti-VEGF therapy with the same medication before study enrollment for a mean of 21.9 injections. The mean central subfield thickness decreased from 419.7 μm at enrollment to 334.1 μm at the final visit (P = .01). The mean maximum subretinal fluid height decreased from 126.6 μm at enrollment to 49.5 μm at the final visit (P = .02). The mean maximum pigment epithelial detachment height decreased from 277.4 μm at enrollment to 239.9 μm at the final visit (P = .12). The mean logMAR visual acuity were 0.54 at enrollment and 0.48 at the final visit (P = .60).
These data suggest that topical dorzolamide-timolol may reduce central subfield thickness and subretinal fluid in eyes with persistent exudation despite consistent, fixed-interval intravitreous anti-VEGF treatment for neovascular AMD.
有一部分患有新生血管性年龄相关性黄斑变性（AMD）的患者，尽管接受了固定间隔的玻璃体内抗血管内皮生长因子（VEGF）注射，但仍存在持续性渗出。
评估局部多佐胺盐酸盐-马来酸噻吗洛尔对新生血管性 AMD 且对抗 VEGF 治疗反应不完全的患者的解剖和功能结局的影响。
设计、地点和参与者：在一家三级转诊学术私人诊所进行的探索性、前瞻性单臂干预性研究。纳入了有新生血管性 AMD 且尽管接受了固定间隔的玻璃体内抗 VEGF 治疗，但仍存在持续性黄斑水肿的患者。在基线时进行频域光学相干断层扫描和临床数据（包括视力和眼内压）的采集，包括在纳入前的一次就诊时和纳入前的一次就诊时。该研究于 2015 年 2 月 1 日至 2015 年 9 月 30 日在威尔斯眼医院的视网膜科和大西洋中部视网膜科的办公室进行。患者在纳入后至少随访 2 次就诊。在每次就诊时记录中央视网膜下厚度、最大视网膜下液高度和最大色素上皮脱离高度。
纳入的眼睛接受局部多佐胺-噻吗洛尔治疗，每天 2 次，并在研究期间继续按照与纳入前相同的间隔接受相同的玻璃体内抗 VEGF 治疗。
中央视网膜下厚度的变化是主要结局测量指标。视网膜下液最大高度、最大色素上皮脱离高度和视力的变化是次要结局测量指标。
10 名患者（10 只眼）完成了研究。患者的平均年龄为 78.2 岁（年龄范围，65-91 岁），其中 6 名为男性。8 只眼接受了玻璃体内阿柏西普治疗，2 只眼接受了玻璃体内雷珠单抗治疗。所有研究眼在研究纳入前都接受了相同药物的长期抗 VEGF 治疗，平均注射 21.9 次。中央视网膜下厚度从纳入时的 419.7μm 降至最后一次就诊时的 334.1μm（P = .01）。最大视网膜下液高度从纳入时的 126.6μm 降至最后一次就诊时的 49.5μm（P = .02）。最大色素上皮脱离高度从纳入时的 277.4μm 降至最后一次就诊时的 239.9μm（P = .12）。平均 logMAR 视力从纳入时的 0.54 降至最后一次就诊时的 0.48（P = .60）。
这些数据表明，局部多佐胺-噻吗洛尔可能会减少中央视网膜下厚度和视网膜下液，在持续存在渗出的情况下，即使接受了固定间隔的玻璃体内抗 VEGF 治疗新生血管性 AMD 也是如此。
