Marques João Pedro, Farinha Cláudia, Costa Miguel Ângelo, Ferrão Ângela, Nunes Sandrina, Silva Rufino
Association for Investigation and Biomedical Research on Light and Image (AIBILI), Coimbra, Portugal.
Faculty of Medicine, University of Coimbra (FMUC), Coimbra, Portugal.
BMJ Open. 2017 Aug 28;7(8):e015785. doi: 10.1136/bmjopen-2016-015785.
The purpose of this study is to compare the efficacy and safety of intravitreal aflibercept (IVA) with sham photodynamic therapy (sPDT) versus IVA with verteporfin PDT (vPDT) in a Caucasian population with treatment-naive polypoidal choroidal vasculopathy (PCV), enrolling into a treat and extend (T&E) regimen.
Randomised, double-masked, sham-controlled, multicentre phase 4 investigator-driven clinical trial. The primary outcomes are (1) change in best-corrected visual acuity (BCVA) from baseline and (2) polyp regression at week 52, assessed by indocyanine green angiography (ICGA). Fifty patients with treatment-naive PCV will be recruited from Portuguese and Spanish clinical sites. Eligible patients will receive monthly IVA for 3 months (week 0, week 4 and week 8). At week 16, all patients will repeat ICGA and undergo central randomisation (1:1 ratio) into one of the following groups: Group 1-IVA T&E + vPDT; Group 2-IVA T&E + sPDT. PDT will be performed at week 16, week 28 and week 40 in the presence of active polyps. After week 16, the presence of macular fluid on optical coherence tomography will determine the schedule of observations. When present, the interval between visits/injections will decrease 2 weeks (minimum 6 weeks). When not, the interval between visits/injections will increase 2 weeks (maximum 12 weeks). Efficacy will be evaluated based on BCVA, central retinal thickness and polyp regression. Safety parameters will include assessment of intraocular pressure, adverse events and serious adverse events.
This study was designed and shall be implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines for Good Clinical Practice, with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki. The study received approval from Comissão de Ética para a Investigação Clínica and Comité Ético de investigación Clínica del Hospital Universitari de Bellvitge.
This study is registered under the EudraCT number: 2015-001368-20 and the ClinicalTrials.gov Identifier: NCT02495181.
本研究旨在比较玻璃体内注射阿柏西普（IVA）联合假光动力疗法（sPDT）与IVA联合维替泊芬光动力疗法（vPDT）在初治息肉状脉络膜血管病变（PCV）白种人群中的疗效和安全性，并采用治疗并延长（T&E）方案。
随机、双盲、假对照、多中心4期研究者发起的临床试验。主要结局指标为：（1）最佳矫正视力（BCVA）较基线的变化；（2）第52周时息肉消退情况，通过吲哚菁绿血管造影（ICGA）评估。将从葡萄牙和西班牙的临床机构招募50例初治PCV患者。符合条件的患者将每月接受一次IVA治疗，共3个月（第0周、第4周和第8周）。在第16周时，所有患者将重复进行ICGA检查，并按1:1比例进行中心随机分组，分为以下两组：第1组-IVA T&E + vPDT；第2组-IVA T&E + sPDT。在有活动性息肉时，将在第16周、第28周和第40周进行PDT治疗。第16周后，光学相干断层扫描显示黄斑区有无积液将决定观察计划。有积液时，就诊/注射间隔将缩短2周（最短6周）。无积液时，就诊/注射间隔将延长2周（最长12周）。将根据BCVA、中心视网膜厚度和息肉消退情况评估疗效。安全性参数将包括眼压评估、不良事件和严重不良事件。
本研究按照国际协调会议（ICH）统一的三方良好临床实践指南、适用的当地法规以及《赫尔辛基宣言》规定的伦理原则进行设计、实施和报告。本研究已获得临床研究伦理委员会和贝尔维尤大学医院临床研究伦理委员会的批准。
本研究已在欧盟临床试验数据库（EudraCT）注册，注册号为：2015 - 001368 - 20，在美国国立医学图书馆临床试验注册平台（ClinicalTrials.gov）的标识符为：NCT02495181。
