NCT01787669已完成2 期
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Proportion of eyes that have central macular thickness <300 microns 6 months after switching
研究概览
简要总结
The specific aim of the study is to test the following hypothesis:
That switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with diabetic macular oedema with no or incomplete response from one therapy is beneficial.
详细描述
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyes Previously Treated with bevacizumab:
- •Diabetic macular oedema affecting the fovea that has persisted despite ongoing, monthly intravitreal injections of bevacizumab over at least 6 months, the last being 2 to 3 months prior to the screening visit.
- •There must be an historical OCT available from 1-4 weeks after the last bevacizumab injection with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to bevacizumab.
- •At screening, the bevacizumab treated eye must have DMO with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT
- •Eyes Previously Treated with dexamethasone:
- •Diabetic macular oedema affecting the fovea that has persisted despite two dexamethasone implants 5 or fewer months apart, the last being 5-8 months prior to the screening visit.
- •There must be an historical OCT available from 8-14 weeks after the last dexamethasone implant with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to the dexamethasone implant.
- •At screening, the dexamethasone treated eye must have DMO with retinal thickness > 300 microns in central 1mm subfield on Spectral domain OCT
- •Age >= 18 years
- •Diagnosis of diabetes mellitus
- •Best corrected visual acuity of 20-78 letters (approx 6/120 -6/7.5)
- •Previous macular laser treatment, or the investigator believes laser treatment is unlikely to be helpful
- •Intraocular pressure <22mmHg
- •Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised
- •Written informed consent has been obtained.
排除标准
- •Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar TA within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months.
- •Cataract surgery within the last 3 months
- •Retinal laser treatment within the last 3 months
- •For eyes to be switched to Dexamethasone: Patient considered, at the judgement of the investigator, to be at-risk for syphilis, tuberculosis or other potentially infective chorioretinopathies. Patients considered at-risk may be assessed at the investigators discretion to reasonably exclude these conditions. Should these conditions be excluded, the patient may be considered for enrolment.
研究组 & 干预措施
Avastin (bevacizumab)
Active Comparator
Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria
干预措施: Avastin (Bevacizumab) (Drug)
Ozurdex (dexamethasone)
Active Comparator
single dose at baseline and repeat dose when required according to defined re-treatment criteria
干预措施: Ozurdex (dexamethasone) (Drug)
结局指标
主要结局
Proportion of eyes that have central macular thickness <300 microns 6 months after switching
时间窗: 6 months
次要结局
- Mean change in central macular thickness (CMT) as measured by OCT.(6 months)
研究者
研究点 (3)
Loading locations...
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