Murray Timothy G, Latiff Azeema, Villegas Victor M, Gold Aaron S
Murray Ocular Oncology and Retina, Miami, Florida.
Murray Ocular Oncology and Retina, Miami, Florida.
Ophthalmol Retina. 2019 Jul;3(7):561-566. doi: 10.1016/j.oret.2019.02.009. Epub 2019 Feb 27.
To evaluate 2 treatment approaches to intravitreal vascular endothelial growth factor antagonist therapy in radiation maculopathy comparing aflibercept delivered by either a 6-week treatment interval or treat-and-adjust interval.
Randomized, prospective clinical trial.
Forty consecutive patients were enrolled in an institutional review board-approved clinical trial and randomized to aflibercept treatment via 1 of 2 regimens: (1) fixed, every-6-weeks treatment or (2) variable, treat-and-adjust treatment centered around 6 weeks. All patients had a diagnosis of treated uveal melanoma with documented tumor control. All patients showed visually compromising radiation maculopathy confirmed by a decline in best-corrected visual acuity (BCVA) and spectral-domain (SD) OCT documentation of radiation maculopathy.
Best-corrected visual acuity and SD OCT central retinal thickness at 1 year.
Thirty-nine of 40 patients completed the trial (97.5%) with 1 year of follow-up. Baseline study entry BCVA was 20/63 and was maintained at 20/62 at study conclusion at 60 weeks (1 year). At baseline, SD OCT mean central retinal thickness was 432 μm and improved to 294 μm at 60 weeks (P < 0.02). At the study conclusion, 42.5% of eyes (17/40) showed better than 20/50 BCVA, and only 5% of eyes (2/40) showed a BCVA worse than 20/200. In the every-6-weeks interval treatment arm, patients received 9 injections, whereas in the treat-and-adjust study arm, patients received 8.4 injections (P = 0.88, not significant). One patient experienced an inflammatory response after aflibercept injection, but this did not occur again for this patient, nor for any other study injections (1/400 injections [0.0025%]). No patients demonstrated endophthalmitis or metastatic disease or died during the study window.
Aflibercept seems to limit vision loss associated with radiation maculopathy. In this randomized, prospective clinical study, no difference was found between a fixed 6-week treatment interval and a variable treat-and-adjust interval because virtually all patients required treatment every 6 weeks and were not able to extend. Remarkably, almost half of all treated patients maintained BCVA of 20/50 or better throughout 1 year of treatment. Aflibercept is effective in treating radiation maculopathy, but requires an ongoing treatment approach.
评估玻璃体内血管内皮生长因子拮抗剂治疗放射性黄斑病变的两种治疗方法，比较每6周给药一次和根据病情调整给药间隔的阿柏西普治疗效果。
随机、前瞻性临床试验。
40例连续患者参加了一项经机构审查委员会批准的临床试验，并随机分为两种治疗方案之一接受阿柏西普治疗：（1）固定的每6周治疗方案；（2）以6周为中心的可变的按需调整治疗方案。所有患者均诊断为已接受治疗的葡萄膜黑色素瘤且肿瘤得到控制。所有患者均表现出最佳矫正视力（BCVA）下降及光谱域（SD）光学相干断层扫描（OCT）证实的放射性黄斑病变，导致视力受损。
1年后的最佳矫正视力和SD OCT测量的中心视网膜厚度。
40例患者中有39例（97.5%）完成了为期1年的随访。研究入组时的基线BCVA为20/63，在60周（1年）研究结束时维持在20/62。基线时，SD OCT测量的中心视网膜平均厚度为432μm，60周时改善至294μm（P<0.02）。研究结束时，42.5%的患眼（17/40）BCVA优于20/50，只有5%的患眼（2/40）BCVA低于20/200。在每6周给药一次的治疗组中，患者接受了9次注射，而在按需调整治疗组中，患者接受了8.4次注射（P = 0.88，无统计学意义）。1例患者在注射阿柏西普后出现炎症反应，但该患者及其他任何研究注射均未再次出现（400次注射中有1次[0.0025%]）。在研究期间，没有患者发生眼内炎或转移性疾病，也没有患者死亡。
阿柏西普似乎能限制与放射性黄斑病变相关的视力丧失。在这项随机、前瞻性临床研究中，固定的6周治疗间隔和可变的按需调整间隔之间未发现差异，因为几乎所有患者都需要每6周治疗一次且无法延长间隔。值得注意的是，在整个1年的治疗过程中，几乎一半的治疗患者维持了20/50或更好的BCVA。阿柏西普在治疗放射性黄斑病变方面有效，但需要持续的治疗方法。
