Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Visual accuty assessed by snellen chart
研究概览
简要总结
The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include:
- Functional changes: The visual outcomes achieved by testing visual acuity
- Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).
详细描述
Brief summary template The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include:
- Functional changes: The visual outcomes achieved by testing visual acuity
- Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).
The secondary objectives include:
- Analyze the cost-effectiveness of bevacizumab versus aflibercept in the management of diabetic maculopathies.
- Safety profile and adverse events reported with bevacizumab and aflibercept use and their association with changes functioning changes
Patients inclusion criteria include patients both sexes, age over 40 years with type 2 diabetes mellites diagnosed with diabetic maculopathies; those patients with reduced or reducing vision (6/9-6/90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellites.
- •Patients diagnosed with diabetic maculopathies, including focal and diffuse maculopathies, according to Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria
- •Patients with reduced or reduced vision (6/9-6/90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm)
- •Patients will be treated with intravitreal anti-VEGF treatment, aflibercept, or bevacizumab for three successive monthly injections.
排除标准
- •Patients with type 1 diabetes mellites
- •Patients with type 2 on insulin therapy.
- •Patients who were previously treated with intravitreal anti-VEGF within the previous three months or intravitreal corticosteroids for six months
- •Prior macular photocoagulation or photodynamic therapy, prior intraocular surgeries within three months (laser & surgery may cause edema)
- •Pregnant or nursing women
- •In patients with a history of thromboembolic events, systemic VEGF inhibition is likely to cause cardiovascular complications, such as arterial thromboembolic events.
- •Patients major surgery within the previous one year or planned within the next few months that may interfere with anti-VEGF treatment
- •Uncontrolled hypertension as hypertension is associated with the use of VEGF antagonists.
- •Known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
- •Hemorrhagic macular infarction is reported with the use of VEGF antagonists.
- •Patients with intraocular pressure more than 25 mmHg
- •Presence of iris neovascularization/vitreous hemorrhage
研究组 & 干预措施
Bevacizumab group
Patients will receive an intravitreal injection of 1.25 mg (in 0.05 ml solution) of bevacizumab once monthly for three consecutive months.
干预措施: Bevacizumab Injection [Avastin] (Drug)
Aflibercept group
Patients will receive an intravitreal injection of 2.0 mg (in 0.05 ml solution) of aflibercept once monthly for three consecutive months.
干预措施: Aflibercept 2Mg/0.05Ml Inj,Oph (Drug)
结局指标
主要结局
Visual accuty assessed by snellen chart
时间窗: one day before start of treatment, and after 3 months of starting the treatment
The visual outcomes achieved by testing visual acuity by snellen chart
Central fovial thinkness by OCT
时间窗: one day before start of treatment, and after 3 months of starting the treatment
Macular thickness by optical coherence tomography (OCT)
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(During the three months after starting the treatment till the end of follow-up.)
- Quality of life assessed by Visual Functioning Questionnaire 25 (ARB-VFQ-25)(one day before start of treatment, and after 3 months of starting the treatment)
- Adherence assessed by Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT)(one day before start of treatment, and after 3 months of starting the treatment)
研究者
Mohammed Mahmood Mohammed
Principal Investigator
Al-Mustansiriyah University