Disorganization of retinal inner layers as a biomarker in patients with center involving diabetic macular oedema treated with intravitreal bevacizumab
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- • The correlation between DRIL and functional (BCVA) and anatomical (CST) outcomes over 6 months.
研究概览
简要总结
Diabetic macular oedema (DME) is a sight threatening complication of Diabetic Retinopathy, affecting more than 20% patients of long-standing Diabetes. Anti vascular endothelial growth factor injections are the first line treatment for DME which improves visual acuity and resolves macular oedema in majority of patients.
Optical coherence tomography is an indispensable tool for the diagnosis, treatment and follow-up of patients with DME. Sun et.al in 2014 showed a new morphologic feature on SD-OCT known as disorganization of retinal inner layers ( DRIL) in cases of DME. Disorganization of retinal inner layers (DRIL) essentially describes the inability to delineate the inner retinal layer boundaries within the central retina.Amelioration of DRIL after 4 months treatment with anti-VEGF in eyes with DME was found to be predictive for better visual outcome in DME after 12 months[8]. DRIL seen on fewer OCT scans was shown to be associated with good VA after resolution of centre-involving DME . A recent study further solidified the importance of DRIL as a relevant noninvasive biomarker by demonstrating an association between DRIL and increasing severity of diabetic retinopathy
While the association between the presence of DRIL and VA has been well established, it has not been reported before if current treatment measures are able to affect the severity of DRIL.
Purpose**:** To investigate disorganization of retinal inner layers as a biomarker in eyes with centre involving diabetic macular oedema treated with intravitreal bevacizumab.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 18 years of age, compliant for follow-up and willing to participate
- •Patients of type I and type II Diabetes mellitus presenting with diabetic macular oedema resulting in visual loss
- •Study eye having best corrected visual acuity of less than 6/
- •Macular oedema defined clinically and by SD- OCT as retinal thickness of more than 250µm in the central sub-field and presence of intra or sub-retinal fluid .
- •Treatment with intravitreal bevacizumab (atleast one injection) in past 6 months.
排除标准
- •Other retinal diseases which can cause macular oedema like retinal vascular disorders, choroidal neovascular membrane secondary to age related macular degeneration or any other cause, uveitis
- •Recent history of any intraocular surgery leading to macular oedema
- •Any other cause of loss of visual acuity except cataract.
结局指标
主要结局
• The correlation between DRIL and functional (BCVA) and anatomical (CST) outcomes over 6 months.
时间窗: • The correlation between DRIL and functional (BCVA) and anatomical (CST) outcomes over 6 months.
次要结局
- • The change in DRIL after treatment with intra vitreal bevacizumab and the correlation between patients’ clinical and OCT measures and DRIL during the study period.(6 MONTHS)
研究者
Dr Deepa Ajitkumar
N KP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital