Silpa-Archa Sukhum, Nganthavee Variya, Chotcomwongse Peranut, Lalitwongsa Pawas, Ruamviboonsuk Paisan
Department of Ophthalmology, Rajavithi Hospital, College of Medicine, Rangsit University, 2, Phayathai Road, Ratchathewi District, Bangkok, 10400, Thailand.
Department of Ophthalmology, Priest Hospital, 445 Si Ayutthaya Road, Ratchathewi District, Bangkok, 10400, Thailand.
Ophthalmol Ther. 2025 Jun 7. doi: 10.1007/s40123-025-01172-5.
Refractory diabetic macular edema (DME) is challenging in resource-limited settings, where costly alternatives such as non-bevacizumab anti-vascular endothelial growth factors (VEGFs) and corticosteroid implants are inaccessible. In Thailand, budget constraints exclude these drugs from healthcare schemes covering 92% of the population, a common issue in developing Asian countries. Therefore, this study aimed to evaluate the treatment outcome of repeated intravitreal triamcinolone acetonide (IVTA) dosages for DME refractory to intravitreal bevacizumab over a 12-month period using a decision algorithm.
This was a comparative retrospective study. The included patients were randomly divided into two groups that received either 2 mg or 4 mg IVTA, following a decision algorithm. The primary outcome was the difference in central macular thickness (CMT) between the 2 mg IVTA and 4 mg IVTA groups at 6-month and 12-month follow-up visits.
Overall, 81 eyes (62 patients) with DME refractory to bevacizumab were enrolled. The study involved 53 eyes (37 cases) divided into two groups: group 1 (2 mg IVTA) of 14 eyes, and group 2 (4 mg IVTA) of 39 eyes. The 4 mg IVTA group had a higher initial CMT than their 2 mg IVTA counterparts (P = 0.02). This difference disappeared after 6 and 12 months. The improvement in CMT in both groups was maintained across the 6- and 12-month follow-up periods compared with baseline. Univariate logistic regression analysis revealed that patients with thinner CMT before IVTA treatment had a greater probability of being DME-free over long-term follow-up.
Repeated IVTA treatments for DME refractory to bevacizumab over a 12-month period demonstrated efficacy and appeared to have a comparable safety profile. Patients with thinner CMT before IVTA treatment had a greater probability of remaining DME-free after IVTA treatment.
在资源有限的环境中，难治性糖尿病性黄斑水肿（DME）是一项具有挑战性的问题，因为诸如非贝伐单抗抗血管内皮生长因子（VEGF）和皮质类固醇植入物等昂贵的替代方案难以获得。在泰国，预算限制使得这些药物被排除在覆盖92%人口的医疗保健计划之外，这在亚洲发展中国家是一个普遍问题。因此，本研究旨在使用决策算法评估在12个月期间，对玻璃体内注射贝伐单抗难治的DME患者重复玻璃体内注射曲安奈德（IVTA）剂量的治疗效果。
这是一项比较性回顾性研究。纳入的患者按照决策算法随机分为两组，分别接受2毫克或4毫克的IVTA。主要结局是在6个月和12个月随访时，2毫克IVTA组和4毫克IVTA组之间中心黄斑厚度（CMT）的差异。
总体而言，纳入了81只对贝伐单抗难治的DME患者的眼睛（62例患者）。该研究涉及53只眼睛（37例），分为两组：第1组（2毫克IVTA）14只眼睛，第2组（4毫克IVTA）39只眼睛。4毫克IVTA组的初始CMT高于2毫克IVTA组（P = 0.02）。6个月和12个月后这种差异消失。与基线相比，两组CMT的改善在6个月和12个月的随访期内均得以维持。单因素逻辑回归分析显示，IVTA治疗前CMT较薄的患者在长期随访中无DME的可能性更大。
在12个月期间，对贝伐单抗难治的DME患者重复进行IVTA治疗显示出疗效，并且似乎具有相当的安全性。IVTA治疗前CMT较薄的患者在IVTA治疗后无DME的可能性更大。
