Gilson Marta M, Bressler Neil M, Jabs Douglas A, Solomon Sharon D, Thorne Jennifer E, Wilson David J
Johns Hopkins University, Baltimore, Maryland, USA.
Ophthalmology. 2007 Sep;114(9):1713-21. doi: 10.1016/j.ophtha.2007.03.071.
To evaluate fluorescein angiographic and visual acuity (VA) outcomes from patients enrolled in a trial of a single periocular corticosteroid injection immediately before photodynamic therapy (PDT) versus PDT alone for subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Randomized 2-center clinical trial.
Sixty-seven subjects with AMD, subfoveal choroidal neovascularization, and best-corrected VA of 20/20 to 20/320 in the study eye who had received no more than 1 prior PDT treatment.
Subjects were randomized to receive PDT alone (no corticosteroid) or a single periocular corticosteroid injection given via the posterior superior sub-Tenon's capsule route before PDT (corticosteroid) and assessed 1, 3, and 6 months after enrollment. Best-corrected VA and intraocular pressure (IOP) measurements were taken during each examination. Color photographs and fluorescein angiograms were taken at baseline and 3 and 6 months.
Presence or absence of fluorescein leakage from choroidal neovascularization 3 months after randomization.
Between the 34 participants randomized to periocular corticosteroid and 33 to no corticosteroid, baseline features appeared balanced. Thirty-three corticosteroid participants and 30 no corticosteroid participants returned for the 3-month follow-up, at which time 56 had fluorescein leakage. Proportions of participants with leakage at 3 months for the 2 treatment groups did not statistically significantly differ; 94% of the corticosteroid group and 90% of the no corticosteroid group had fluorescein leakage at 3 months (P = 0.66). Mean VAs at 3 months after enrollment were 20/100 and 20/125 in the corticosteroid and no corticosteroid groups, respectively, decreasing on average 1.5 and 0.9 lines from baseline (P = 0.50). Adverse events included IOP > 21 mmHg in 7 corticosteroid participants (21%) and 1 (3%) no corticosteroid participant (P<0.05) and ptosis of the study eyelid in 1 (3%) corticosteroid participant.
In contrast to previously reported uncontrolled studies and 1 controlled study, this trial did not find a reduction in the amount of fluorescein leakage 3 months after a single periocular injection of corticosteroid and PDT compared with PDT alone.
评估在光动力疗法(PDT)之前立即进行单次眼周皮质类固醇注射的试验与单独进行PDT治疗年龄相关性黄斑变性(AMD)继发的黄斑下脉络膜新生血管形成患者的荧光素血管造影和视力(VA)结果。
随机2中心临床试验。
67名患有AMD、黄斑下脉络膜新生血管形成且研究眼最佳矫正视力为20/20至20/320且之前接受过不超过1次PDT治疗的受试者。
受试者被随机分为单独接受PDT(无皮质类固醇)或在PDT之前通过后上睑下Tenon囊途径进行单次眼周皮质类固醇注射(皮质类固醇),并在入组后1、3和6个月进行评估。每次检查时测量最佳矫正视力和眼压(IOP)。在基线以及3个月和6个月时拍摄彩色照片和荧光素血管造影。
随机分组后3个月脉络膜新生血管是否存在荧光素渗漏。
在随机分配接受眼周皮质类固醇的34名参与者和未接受皮质类固醇的33名参与者之间,基线特征似乎平衡。33名接受皮质类固醇治疗的参与者和30名未接受皮质类固醇治疗的参与者返回进行3个月的随访,此时有56人存在荧光素渗漏。两个治疗组在3个月时出现渗漏的参与者比例在统计学上无显著差异;皮质类固醇组94%和无皮质类固醇组90%在3个月时出现荧光素渗漏(P = 0.66)。入组后3个月时,皮质类固醇组和无皮质类固醇组的平均视力分别为20/100和20/125,平均比基线下降1.5行和0.9行(P = 0.50)。不良事件包括7名(21%)接受皮质类固醇治疗的参与者和1名(3%)未接受皮质类固醇治疗的参与者眼压>21 mmHg(P<0.05),以及1名(3%)接受皮质类固醇治疗的参与者出现研究眼睑上睑下垂。
与先前报道的非对照研究和1项对照研究不同,本试验未发现与单独进行PDT相比,单次眼周注射皮质类固醇和PDT后3个月荧光素渗漏量有所减少。