The effect of combination therapy with intravitreal bevacizumab and topical timolol–dorzolamide eye drops on diabetic macular edema: a double-blind randomized controlled trial,International Ophthalmology

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The effect of combination therapy with intravitreal bevacizumab and topical timolol–dorzolamide eye drops on diabetic macular edema: a double-blind randomized controlled trial
International Ophthalmology ( IF 1.4 ) Pub Date : 2024-02-20 , DOI: 10.1007/s10792-024-03005-z
Sahba Fekri _{1,

2} , Ali Rabiei _{1,

2} , Sadid Hooshmandi _{1,

2} , Hosein Nouri _{1,

3} , Seyed-Hossein Abtahi _{1,

2}

Affiliation

Background

The mainstay of treatment in diabetic macular edema (DME) is intravitreal administration of anti-vascular endothelial growth factors (anti-VEGFs). Aqueous depressants may enhance the effects of anti-VEGF agents by prolonging their clearance via aqueous outflow.

Purpose

To compare the anatomical and functional outcomes of treatment with intravitreal bevacizumab (IVB) and topical timolol–dorzolamide versus IVB alone.

Method

In this randomized placebo-controlled clinical trial, patients with center-involving DME (ci-DME) and best corrected visual acuity (BCVA) of 20/30 or less were enrolled and randomly allocated to two treatment arms. One group received three monthly IVB injections and timolol–dorzolamide eye drops twice a day (IVB + TD group); the other group received three monthly IVB injections and artificial tear drops as placebo (IVB group). Patients underwent ophthalmic evaluations and macular optical coherence tomography scans at baseline and 1 month after the third injection.

Result

Forty-six eyes from 46 patients with ci-DME were recruited. There was no intergroup difference regarding age, gender distribution, diabetic retinopathy stage, glycemic indices, BCVA, central macular thickness (CMT), or intraocular pressure at baseline. BCVA was significantly improved in the IVB + TD group (0.46 ± 0.18 to 0.36 ± 0.18 logarithm of the minimum angle of resolution [logMAR], p = 0.002), in contrast to IVB group (0.40 ± 0.17 to 0.35 ± 0.22 logMAR, p = 0.113). Similarly, the IVB + TD group showed a significant reduction in CMT (p < 0.001), unlike the IVB group (p = 0.086); and the CMT change in the former was greater than in the latter (− 0.57 ± 57.67 vs. − 25.52 ± 68.02 μm, p = 0.033).

Conclusion

Our findings support the short-term effectiveness of topical timolol–dorzolamide as adjunctive therapy to IVB injections in managing center-involving DME in terms of anatomical and visual outcomes. Trial registration: Clinicaltrials.gov NCT05083689 (October 19, 2021).

中文翻译：

玻璃体内注射贝伐单抗和外用噻吗洛尔-多佐胺滴眼液联合治疗糖尿病黄斑水肿的效果：双盲随机对照试验

背景

糖尿病性黄斑水肿（DME）的主要治疗方法是玻璃体内注射抗血管内皮生长因子（抗 VEGF）。水性抑制剂可以通过水流出延长抗 VEGF 药物的清除率，从而增强抗 VEGF 药物的作用。

目的

比较玻璃体内贝伐单抗 (IVB) 和局部噻吗洛尔-多佐胺与单独 IVB 治疗的解剖学和功能结果。

方法

在这项随机安慰剂对照临床试验中，入组中心参与 DME (ci-DME) 且最佳矫正视力 (BCVA) 为 20/30 或更低的患者，并随机分配到两个治疗组。一组接受三个月一次的 IVB 注射和每天两次的噻吗洛尔-多佐胺滴眼液（IVB + TD 组）；另一组接受三个月的 IVB 注射和人工泪液作为安慰剂（IVB 组）。患者在基线和第三次注射后 1 个月接受眼科评估和黄斑光学相干断层扫描。

结果

招募了 46 名 ci-DME 患者的 46 只眼睛。基线时年龄、性别分布、糖尿病视网膜病变分期、血糖指数、BCVA、中央黄斑厚度（CMT）或眼压没有组间差异。 IVB + TD 组的 BCVA 显着改善（0.46 ± 0.18 至 0.36 ± 0.18 最小分辨率对数 [logMAR]， p = 0.002），而 IVB 组则为（0.40 ± 0.17 至 0.35 ± 0.22 logMAR， p = 0.002） = 0.113）。同样，与 IVB 组不同（ p = 0.086），IVB + TD 组的 CMT 显着降低（ p < 0.001）；前者的 CMT 变化大于后者（− 0.57 ± 57.67 vs. − 25.52 ± 68.02 μm， p = 0.033）。