Comparative Study Between Intravitreal and Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
Intravitreal triamcinolone acetonide is a well-known method of treatment of diabetic macular edema, however, it has many side effects, most commonly causing cataract and glaucoma. Suprachoroidal route is an emerging route of delivery of intraocular drugs.
This is to our knowledge the first prospective study to compare the effect of triamcinolone acetonide delivered via the intravitreal versus the suprachoroidal route in the treatment of diabetic macular edema as regards safety and efficacy.
详细描述
The purposes of this study were:
- To compare between intravitreal and suprachoroidalTA injection for treatment of DME in terms of improvement in both best corrected visual acuity (BCVA) and central macular thickness (CMT), and development of complications.
- To identify which dose of TA will be efficient using the suprachoroidal route.
- Type of Study: A prospective interventional randomized comparative study.
- Study setting:Ophthalmology Department, Ain Shams University.
- Study period:2 years.
- Study population: Patients having DME.
- Sample size: The study will be conducted on 45 eyes. This was done using PASS program, setting alpha error at 5% and power at 80%. Results from previous study (Koc et al., 2017) showed that the mean improvement in BCVA after 6 months of intravitreal injection of TA was 4.6 ± 8.8. While it is assumed to be 12.6 and 14.6 for the low dose and high dose suprachoroidal route.
- Ethical considerations: Explanation of the procedure will be done for all patients and an informed written consent will be taken. Ethics committee approval will be obtained from the Institutional Review Board of the Faculty of Medicine, Ain Shams University.
All patients will undergo the following at initial presentation:
- Careful history taking.
- Full ophthalmological assessment including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type-II Diabetes Mellitus patients.
- •Centrally involving DME with central thickness<300µm with no vitreomacular traction.
- •Recently diagnosed DME or received treatment for DME in more than six months.
排除标准
- •Pre-existingretinal disease other than diabetic retinopathy.
- •Diabetic macular ischemia.
- •IOP ≥ 21 mmHg and/or asymmetrical cup disc ratio or glaucoma patients.
- •Prior cataract extraction of less than six months.
- •Opaque media, uncooperative patients or patients with poor fixation.
- •Any uncontrolled systemic disease.
- •Systemic or local medicationsthat might affect the macular thickness
研究组 & 干预措施
Study group I : Intravitreal injection
A single intravitreal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml.
干预措施: Intravitreal injection (4mg/0.1ml) (Procedure)
Study group II: Suprachoroidal injection of full dose
A single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml.
干预措施: Superachoroidal injection (4 mg/0.1ml) (Procedure)
Study group III : Suprachoroidal injection of half dose
They will receive a single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 2 mg / 0.1 ml.
干预措施: Suprachoroidal injection (2mg/0.1ml) (Procedure)
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: Six months after injection
Change in BCVA (Log.MAR) equal or more than 1 line
次要结局
- Complications(During the six months after injection)
- Central macular thickness (CMT)(Six months after injection)
研究者
Azza Mohamed Ahmed Said
Professor of Ophthalmology
Ain Shams University