Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Ophthalmology, Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Int Ophthalmol. 2022 Nov;42(11):3345-3356. doi: 10.1007/s10792-022-02333-2. Epub 2022 May 11.
Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes.
In this randomized clinical trial, 83 eyes of 83 patients with DME were recruited and divided into three groups: normal vitamin D levels + IVB administration (Group 1), vitamin D insufficient/deficient + IVB administration (Group 2), and vitamin D insufficient/deficient + IVB administration + oral vitamin D supplementation (Group 3). Participants were followed for 6 months after the intervention. Visual (corrected distance visual acuity, CDVA) and anatomical (central macular thickness, CMT) outcomes of intervention were evaluated 1, 3, and 6 months after three monthly loading doses of IVB were given. Serum vitamin D levels were measured 1 and 6 months after the third IVB administration.
A total of 29, 26, and 28 eyes were enrolled in groups 1, 2, and 3, respectively. In months 1, 3, and 6, after the three basic loading doses of IVB, visual acuity and CMT improved in all three groups, but improvements (both functional and anatomical) in groups 1 and 3 in month 6 were more significant than in group 2 (mean CDVA LogMAR changes: - 0.18 ± 0.03, - 0.14 ± 0.05, and - 0.2 ± 0.06; mean CMT reductions: - 82.24 ± 11.43, - 66.62 ± 14.34, and - 86.14 ± 18.36, in groups 1, 2, and 3, respectively; p < 0.001). The mean number of IVB injections during follow-up was 5.33 (range 4-7), which did not differ between the groups.
Correction of vitamin D deficiency in DME patients with type 2 diabetes and vitamin D deficiency, in addition to IVB injections, may play a role in improving CDVA and CMT. However, this beneficial effect seems to be delayed by several months.
Iranian Registry of Clinical Trials (IRCT), IRCT20200407046978N1, registered on April 11, 2020, retrospectively registered ( https://en.irct.ir/trial/46999 ).
推测维生素 D 缺乏症（VDD）会加重糖尿病性黄斑水肿（DME）。我们旨在确定纠正低维生素 D 血症对 DME 眼接受玻璃体内贝伐单抗（IVB）治疗结果的影响。
在这项随机临床试验中，招募了 83 例 DME 患者的 83 只眼，并将其分为三组：正常维生素 D 水平+IVB 给药（第 1 组）、维生素 D 不足/缺乏+IVB 给药（第 2 组）和维生素 D 不足/缺乏+IVB 给药+口服维生素 D 补充剂（第 3 组）。在接受三次每月负荷剂量 IVB 治疗后，参与者在干预后 6 个月进行随访。在接受三次每月负荷剂量 IVB 治疗后的第 1、3 和 6 个月评估干预的视觉（矫正后的远视力，CDVA）和解剖学（中央黄斑厚度，CMT）结果。在第三次 IVB 给药后 1 和 6 个月测量血清维生素 D 水平。
第 1、2 和 3 组分别纳入了 29、26 和 28 只眼。在接受三次基础负荷剂量 IVB 后的第 1、3 和 6 个月，所有三组的视力和 CMT 均有所改善，但第 1 和第 3 组在第 6 个月的改善（包括功能和解剖）比第 2 组更显著（平均 CDVA LogMAR 变化：-0.18±0.03、-0.14±0.05 和-0.2±0.06；平均 CMT 减少量：-82.24±11.43、-66.62±14.34 和-86.14±18.36，分别在第 1、2 和 3 组中；p<0.001）。在随访期间，平均 IVB 注射次数为 5.33（范围 4-7），三组之间没有差异。
在 2 型糖尿病合并维生素 D 缺乏的 DME 患者中纠正维生素 D 缺乏症，除了 IVB 注射外，可能有助于改善 CDVA 和 CMT。然而，这种有益的效果似乎要延迟几个月。
伊朗临床试验注册中心（IRCT），IRCT20200407046978N1，于 2020 年 4 月 11 日注册，回溯注册（https://en.irct.ir/trial/46999）。
