Department of Ophthalmology, The University of Sydney Save Sight Institute, Sydney, New South Wales, Australia
Department of Ophthalmology, Sydney and Sydney Eye Hospital, Sydney, New South Wales, Australia.
Br J Ophthalmol. 2023 Jan;107(1):79-83. doi: 10.1136/bjophthalmol-2021-319839. Epub 2021 Aug 2.
The BEVORDEX trial compared outcomes of eyes with diabetic macular oedema (DMO) randomised to receive either intravitreal dexamethasone (DEX-) implant or bevacizumab over 2 years. We assessed long-term efficacy and safety outcomes 5 years from enrolment.
Patients received standard clinical care after they finished the study. Their files were reviewed for visual and anatomical outcomes, post-trial treatments and complications.
Three-year and five-year data were available for 82% and 59% of eyes enrolled in the BEVORDEX study, respectively. Visual acuity gains at end of trial were generally lost by both treatment groups at 5 years but the macular thickness did not change from end of trial to 5 years. A similar proportion of eyes from each treatment group gained ≥10 letters at 5 years from enrolment in the BEVORDEX trial.Eyes that were initially randomised to the DEX-implant group had significantly fewer treatments but were more likely to develop proliferative diabetic retinopathy (PDR) over the 5-year period compared with eyes initially randomised to bevacizumab. The proportion of eyes that had cataract surgery by 5 years was similar between initial treatment groups.
Eyes in the BEVORDEX trial had similar 5-year rates of cataract surgery, however, more eyes converted to PDR in the group initially treated with DEX-implant. Eyes that were initially treated for 2 years with either intravitreal DEX-implant of bevacizumab followed by standard of care had similar visual and anatomical outcomes at 5 years.
BEVORDEX 试验比较了患有糖尿病黄斑水肿（DMO）的患者接受玻璃体内地塞米松（DEX）植入物或贝伐单抗治疗 2 年的结果。我们评估了从入组起 5 年的长期疗效和安全性结果。
患者在完成研究后接受标准临床护理。他们的病历被审查，以评估视力和解剖学结果、试验后治疗和并发症。
分别有 82%和 59%的入组患者可获得 3 年和 5 年的数据。两组在 5 年时视力均较试验结束时有所下降，但黄斑厚度从试验结束到 5 年时并未改变。两组中有相似比例的患者在入组 BEVORDEX 试验 5 年后获得了≥10 个字母的视力提高。最初随机分配到 DEX 植入组的眼睛接受的治疗次数明显较少，但在 5 年内发生增生性糖尿病视网膜病变（PDR）的可能性比最初随机分配到贝伐单抗的眼睛高。在 5 年内，最初接受治疗的两组中接受白内障手术的眼睛比例相似。
在 BEVORDEX 试验中，两组 5 年内白内障手术的发生率相似，但在最初接受 DEX 植入治疗的组中，更多的眼睛转化为 PDR。最初接受玻璃体内 DEX 植入或贝伐单抗治疗 2 年，然后接受标准护理的两组患者在 5 年内的视力和解剖学结果相似。
