Resistant Diabetic Macular Edema and Suprachoroidal Injection
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement of central macular thickness
研究概览
简要总结
Prospective interventional study on 60 eyes of resistant diabetic macular edema and central retinal vein occlusion that will receive suprachoroidal injection of Triamcinolone Acetonide (SCTA).
详细描述
- Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus and 60 eyes with central retinal vein occlusion will be included.
- The study will be conducted from January 2021 to June 2021.
- For transition to suprachoroidal injection of Triamcinolone Acetone (TAAC) a diagnosis of resistant DME is required.
- Inclusion criteria:
Patients fulfilling one or more of the following criteria will be considered to have resistant diabetic macular edema (DME) after at least 3 consecutive monthly anti vascular endothelial growth factor (VEGF) injections in the previous 6 months: central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT), reduction of retinal thickness by less than 10% of baseline retinal thickness, or suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart).
- The subjects included in the research will undergo the following tests and investigations:
- Visual acuity testing (uncorrected and best corrected).
- Intra ocular pressure (IOP) by applanation tonometry.
- Anterior segment examination by slit lamp
- Posterior segment examination by indirect ophthalmoscope and 78 D lens
- Spectral domain Optical coherence tomography (OCT).
- Ocular fundus photography and fluorescein angiography.
- Exclusion criteria will be:
- Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
- Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
- Previous laser photocoagulation.
- Intravitreal injection of triamcinolone acetonide.
- Prior ocular inflammation.
- The presence of retinal degeneration.
- Patients who didnot complete 6 months of follow up
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
盲法说明
code number will be given for each participant
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients fulfilling one or more of the following criteria will be considered to have resistant DME after at least 3 consecutive monthly anti VEGF injections in the previous 6 months:
- •Central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT).
- •Reduction of retinal thickness by less than 10% of baseline retinal thickness.
- •Suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart) and patients with recent onset central retinal vein occlusion less than 3 months.
排除标准
- •Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
- •Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
- •Previous laser photocoagulation.
- •Intravitreal injection of triamcinolone acetonide.
- •Prior ocular inflammation.
- •The presence of retinal degeneration.
- •Patients who didnot complete 6 months of follow up
研究组 & 干预措施
resistant diabetic macular edema and central retinal vein occlusion
- Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus will be included.
- The study will be conducted from January 2021 to June 2021.
- For transition to suprachoroidal injection of TAAC a diagnosis of resistant DME is required.
Cases with recent onset central retinal vein occlusion less than 2 months duration will be included
干预措施: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 (Drug)
结局指标
主要结局
Improvement of central macular thickness
时间窗: 1 month
Reduction of the central macular thickness below 300 um
次要结局
- improved vision(3 months)
研究者
Amin El Sayed Nawar
Lecturer Of Ophthalmology, Tanta university
Tanta University