Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients with Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- _Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.
研究概览
简要总结
Retinal vein occlusion (RVO) is one of the most common causes of vision loss due to retinal vascular disease. Incidence of RVO has been raised in the last years due to increased coexisting systemic vascular risk factors as arterial hypertension, obesity, diabetes mellitus and COVID-19. Macular edema (ME) is a major sight-threatening complication of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). BRVO and CRVO have the same pathology, an elevation in the intravascular pressure in the occluded vein leading to vascular wall damage causing leakage of fluid and release of inflammatory cytokines as vascular endothelial growth factor (VEGF), respectively.
In the past, the standard treatment for BRVO-related ME was grid laser photocoagulation and for CRVO-related ME was observation. But subsequent randomized controlled trials demonstrated significant functional and anatomical improvements among patients with ME secondary to BRVO or CRVO treated with intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors or corticosteroids compared to those treated with laser only. Anti-VEGF therapy decrease intravenous pressure, enhance blood flow and improve venous diameter and tortuosity. Also, intravitreal corticosteroid injection has been shown to improve vision and central macular thickness (CMT).
Dexamethasone intravitreal implant (Ozurdex®, Allergan Inc., Irvine, CA, USA) has potent antiangiogenic and anti-inflammatory effects. Also it decreases the vascular permeability playing an important role in treating ME secondary to RVO. However, majority of eyes have been treated previously then shifted to dexamethasone implant as a second line for treatment of refractory RVO related ME.
详细描述
Aim of the research is To evaluate functional and anatomical outcomes of ozurdex injection in patients with RVO related macular edema.
And evaluation of the safety of ozurdex injections regarding intraocular pressure increase, cataract development or endophthalmitis.
Type of the study: Interventional Case Series. Study Setting: Assiut University Hospital (Ophthalmology Department).
Study subjects:
- Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with macular edema secondary to BRVO and CRVO.
- •Presence of macular edema >3oo μ on OCT evaluation.
- •visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
排除标准
- •Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
- •Media opacities (cataract) that could decrease visual acuity (VA).
- •Previous ocular trauma or vitreoretinal surgery.
- •Patients with glaucoma or known to be steroid responders
结局指标
主要结局
_Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.
时间窗: 2 years
次要结局
- - To evaluate the incidence and onset of occurrence of any adverse event or recurrence.(2 years)
研究者
Menatallah Gamal Saleh
Assistant lecturer of Ophthalmology
Assiut University
