干旱区生态环境知识资源中心(Arid): Intravitreal dexamethasone versus bevacizumab in Aboriginal and Torres Strait Islander patients with diabetic macular oedema: The OASIS study (a randomised control trial)

Arid

DOI	10.1111/ceo.14079
	Intravitreal dexamethasone versus bevacizumab in Aboriginal and Torres Strait Islander patients with diabetic macular oedema: The OASIS study (a randomised control trial)
	Meyer, Joos; Fry, Carly; Turner, Angus; Razavi, Hessom
通讯作者	Meyer, J
来源期刊	CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY
ISSN	1442-6404
EISSN	1442-9071
出版年	2022
卷号	50 期号:5 页码:522-533
英文摘要	Background Frequent intravitreal anti-VEGF injections are impractical for many Aboriginal patients with diabetic macular oedema (DMO). The longer acting intravitreal dexamethasone implant (DEX-implant) is approved for DMO but has not been assessed in an Aboriginal population. Methods This was a prospective, multicentre, randomised, single-masked, non-inferiority clinical trial. Aboriginal adults from Western Australia with DMO were randomised to receive 3-monthly DEX-implant, or monthly intravitreal bevacizumab. The primary outcome was the change in best corrected visual acuity (BCVA) at 12 months. Results The final endpoint was analysed for 24 DEX-implant and 28 bevacizumab injection eyes. Mean BCVA improved by 4.0 letters (-0.08 LogMAR) in the DEX-implant group and worsened by 5.5 letters (0.11 LogMAR) in the bevacizumab group. Before adjusting for cataract surgery, the upper bound of the two-sided 90% CI for the DEX-implant was 3.5 letters (0.07 LogMAR), which met non-inferiority criteria. The BCVA of remote participants who received the DEX-implant improved by 5.5 letters (0.11 LogMAR), compared to an 18.5 letter (0.37 LogMAR) decline for bevacizumab (p = 0.04). The incidence of steroid-induced ocular hypertension for the DEX-implant was 33.3%. Conclusions Before adjusting for the effect of cataract surgery, the DEX-implant was non-inferior to bevacizumab for treating DMO in Aboriginal participants. In remote participants, the DEX-implant surpassed non-inferiority to achieve superior outcomes to bevacizumab. The incidence of steroid-induced hypertension was comparable to that reported in non-Aboriginal populations. We provide guidelines for the judicious use of DEX-implant among Aboriginal people, and a framework for performing ophthalmic clinical trials in Aboriginal communities.
英文关键词	aboriginal Australians bevacizumab dexamethasone implant diabetes diabetic macular Oedema
类型	Article
语种	英语
收录类别	SCI-E
WOS记录号	WOS:000779476400001
WOS关键词	CLINICAL-TRIAL ; PREVALENCE ; RETINOPATHY ; BARRIERS ; RISK
WOS类目	Ophthalmology
WOS研究方向	Ophthalmology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/392157
推荐引用方式 GB/T 7714	Meyer, Joos,Fry, Carly,Turner, Angus,et al. Intravitreal dexamethasone versus bevacizumab in Aboriginal and Torres Strait Islander patients with diabetic macular oedema: The OASIS study (a randomised control trial)[J],2022,50(5):522-533.
APA	Meyer, Joos,Fry, Carly,Turner, Angus,&Razavi, Hessom.(2022).Intravitreal dexamethasone versus bevacizumab in Aboriginal and Torres Strait Islander patients with diabetic macular oedema: The OASIS study (a randomised control trial).CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY,50(5),522-533.
MLA	Meyer, Joos,et al."Intravitreal dexamethasone versus bevacizumab in Aboriginal and Torres Strait Islander patients with diabetic macular oedema: The OASIS study (a randomised control trial)".CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY 50.5(2022):522-533.