Prospective, Single-center, Six-month Study of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-perfused Retinal Area
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- The Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
Title of study:
Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR) with DME assessed by microaneurysm changes: A pilot study Objectives Diabetic retinopathy (DR) is a major cause of visual impairment. Anti-vascular endothelial growth factors have demonstrated therapeutic benefits in diabetic macular edema (DME). We aimed to prospectively analyze the effects of early intensive treatment using intravitreal ranibizumab (IVR) injections in nonproliferative diabetic retinopathy patients with macular edema.
Primary objective:
To investigate other efficacy endpoints including other visual acuity, anatomical change in mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.
Secondary objectives:
To compare microvascular changes assessed by microaneurysm counts and perifoveal non-perfusion area changes and safty in eyes of mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.
详细描述
Title of study:
Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR) with DME assessed by microaneurysm changes: A pilot study
Study Rationale:
Diabetic retinopathy is the leading disease that causes acquired vision loss after 20 by making diabetic macular edema and neovascularization. In recent young generation, as prevalence of type 2 diabetes is growing, the burden of sight-threatening retinopathy is increasing on trend.1 Pathologically, angiogenesis is a main cause that destroys the structure of the eye and induces the visual function disorder as VEGF playing an important role in increasing the migration and proliferation of endothelial cells and increasing the permeability of the blood vessels.2,3 VEGF is made from the endothelial cells of retinal tissue, perivascular cells, pigment endothelial cells by hypoxia. And hypoxic condition of intraocular tissues is a key regulator of intra ocular angiogenesis by VEGF, the balance between VEGF and angiogenesis inhibitors determines the neovascular proliferation in diabetic retinopathy.4 VEGF is also inducing the expression of cell-to-cell contact molecule (intracellular adhesion molecule-1, ICM-1) and the adhesion of leukocytes to help the inflammatory response5, as mediator which destroys the blood retinal barrier, affecting the protein of tight junctions, making a microaneurysm and increasing permeability of capillary, that makes the liquid leakage and macular edema.5,6 Microanuerysm is the earliest clinical manifestations, the saccular local lesion that perivascular cells protruding in damaged areas on the capillary wall. According to Stitt AW et al9, diabetic microaneurysm is non-functioning extrusion of the vascular system from the deep part of inner retinal capillary plexus.
It is sometimes disappeared by being blocked with blood clots, on the other hand, new microanerysm is occurred in the other vascular bed structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (Male & female) ≥40 years of age
- •Type 2 DM
- •Best corrected visual acuity ≥ 20/200 (Snellen equivalent using Early Treatment Diabetic Retinopathy Study chart)
- •central retinal thickness of ≥300 µm on optical coherence tomography
- •nonproliferative diabetic retinopathy (NPDR) with diabetic macular edema
排除标准
- •proliferative diabetic retinopathy
- •Vitreous hemorrhage
- •previous history of vitreoretinal surgery, post-cataract operation status (≤4 months before participation in this study)
- •prior treatment with anti-VEGF drugs, intraocular corticosteroids, and/or retinal laser application
- •Uncontrolled hypertension.
- •Uncontrolled glaucoma.
- •If both eyes met the study inclusion criteria, the more severely affected eye was selected
研究组 & 干预措施
Lucentis
Patients were administered 0.5-mg IVR injections monthly for 6 months.
干预措施: Lucentis (Drug)
结局指标
主要结局
The Best Corrected Visual Acuity (BCVA)
时间窗: 6 months
BCVA was performed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at baseline and 6 months. The BCVA compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Central Macular Thickness(CMT)
时间窗: 6 months
CRT was performed using OCT at each visit. The OCT measured at each visit was analyzed statistically. the CMT compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
次要结局
- The Total Number of Microaneurysm(6 months)
- Safety Parameters(6 months)
- The Microaneurysm Formation Rate(6 months)
- The Microaneurysm Disappearance Rate(6 months)
- The Microaneurysm Turnover(6 months)
- Perifoveal Non-perfusion Area in FAG (mm²)(6 months)
研究者
Yun-Sik Yang
MD, PhD
Wonkwang University Hospital