医学
黄斑变性
视力
自然科学
扁平部
卫生棉条
血管抑制剂
眼科
临床终点
玻璃体切除术
组织纤溶酶原激活剂
贝伐单抗
外科
随机对照试验
脉络膜新生血管
内科学
化疗
作者
Pierre‐Henry Gabrielle,Marie‐Noëlle Delyfer,B. Housset,Jean Baptiste Conart,Joël Uzzan,Laurent Kodjikian,Carl Arndt,Ramin Tadayoni,Ágnes Simonyi,Catherine P. Creuzot Garcher
出处
期刊:Ophthalmology
[Elsevier]
日期:2023-09-01
卷期号:130 (9): 947-957
被引量:6
标识
DOI:10.1016/j.ophtha.2023.04.014
摘要
To compare the efficacy and the safety of submacular hemorrhage (SMH) management using either surgical pars plana vitrectomy (PPV) or pneumatic displacement (PD) with tissue plasminogen activator (tPA) and vascular endothelial growth factor (VEGF) inhibitor added to each arm.Randomized, open-label, multicenter superiority study.Ninety patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older with recent SMH (≤ 14 days) of more than 2 optic disc areas and predominantly overlying the retinal pigment epithelium.Patients were assigned randomly to surgery (PPV, subretinal tPA [maximum, 0.5 ml/50 μg], and 20% sulfur hexafluoride [SF6] tamponade) or PD (0.05 ml intravitreal tPA [50 μg] and 0.3 ml intravitreal pure SF6). Both groups were asked to maintain a head upright position with the face forward at 45° for 3 days after intervention and received 0.5 mg intravitreal ranibizumab at the end of the intervention, at months 1 and 2, as the loading phase, and then on a pro re nata regimen during a 6-month follow-up.The primary efficacy endpoint was mean best-corrected visual acuity (VA) change at month 3. The secondary endpoints were mean VA change at month 6, 25-item National Eye Institute Visual Function Questionnaire composite score value at months 3 and 6, number of anti-VEGF injections, and complications during the 6-month follow-up.Of the 90 patients randomized, 78 patients (86.7%) completed the 3-month efficacy endpoint visit. The mean VA change from baseline to month 3 in the surgery group (+16.8 letters [95% confidence interval (CI), 8.7-24.9 letters]) was not significantly superior to that in the PD group (+16.4 letters [95% CI, 7.1-25.7 letters]; adjusted difference β, 1.9 [-11.0; 14.9]; P = 0.767). Both groups achieved similar secondary outcomes at month 6. No unexpected ocular safety concerns were observed in either group.Surgery did not yield superior visual gain nor additional benefit for SMH secondary to nAMD compared with PD at 3 months, with intravitreal anti-VEGF added to each arm. Both treatment strategies lead to a clinical improvement of VA without safety concerns for SMH over 6 months. Both design and results of the trial cannot be used to establish equivalence between treatments.Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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