Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
研究概览
简要总结
To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.
- •A BCVA approximate Snellen equivalents, 20/40.
排除标准
- •Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.
- •Pan-retinal laser photocoagulation 3 months or less before baseline,
- •Topical ocular or systemic corticosteroids administered for 30 consecutive days.
- •Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),
- •Use of intraocular corticosteroid implants,
- •Uncontrolled glaucoma (intraocular pressure [IOP] 30 mmHg with medication) at the time of screening or baseline,
- •iris neovascularization or neo-vascular glaucoma.
研究组 & 干预措施
Ranibizumab
intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up
干预措施: Ranibizumab (Drug)
Ranibizumab and triamcinolone acetate
intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
干预措施: Ranibizumab (Drug)
Ranibizumab and triamcinolone acetate
intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
干预措施: triamcinolone acetate (Drug)
结局指标
主要结局
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
时间窗: 2 year
To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Optical Coherence Tomography: will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).
次要结局
未报告次要终点
研究者
Wael Ali Mohamed
Principal Investigator
Assiut University