NCT00764244已完成3 期
VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years
研究概览
简要总结
Macular edema is the main cause of vision loss in diabetic patients. Its treatment is mainly based on laser photocoagulation, but has limited results. Alternative treatment are under investigation, such as vitrectomy and intravitreal injections of triamcinolone .The aim of VITRILASE is to compare the efficacy of these two treatments to laser photocoagulation for diabetic macular edema.
详细描述
It is a randomized study with three arms
- vitrectomy
- repeat intravitreal triamcinolone injections
- laser photocoagulation
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with type 1 or type 2 diabetes
- •Visual acuity (VA) : 0.1≤ VA < 0.5 (35 ≤ ETDRS score < 70)
- •Patient with diffuse diabetic macular edema , as defined by :§ Retinal thickening involving the center of the macular on biomicroscopy§ AND diffuse leakage on fluorescein angiography .
- •Macular thickness in the central area 1000 µm in diameter ³ 300 µm.
- •Patient with :· Either diffuse diabetic macular edema · Or combined diffuse and focal diabetic macular edema with persistent diffuse macular edema 6 months after laser treatment of the focal edema .
- •Systolic blood pressure ≤ 160 mmHg and diastolic blood pressure ≤ 90 mmHg.,
- •HbA1c < 10%.
排除标准
- •Patient with tractional diabetic macular edema, as defined by· A taut, thickened posterior hyaloid on biomicroscopy AND/OR· a thickened , highly reflective posterior hyaloid on OCT , partially detached from the posterior pole, and exerting a traction on the macula
- •Active proliferative diabetic retinopathy (ETDRS stage 61 or more severe)
- •Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized central hard exudate plaque³ 1 disk area
- •Hypertensive retinopathy
- •Epiretinal membrane.
- •Rubeosis irides .
- •Patient requiring immediate panretinal photocoagulation or panretinal photocoagulation performed within the past 6 months .
- •History of chronic glaucoma in the study eye
- •History of elevated intraocular pressure ≥30 mm Hg and/or alteration of visual field
- •Concomitant therapy with systemic or topical ocular corticosteroids within the last 15 days .
- •Cataract surgery in the study eye within the past 6 months, Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within the past 6 months,
- •Patient with pseudophakic macula edema
- •Unstable medical status including glycemic control and blood pressure. Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) should not be enrolled.
- •Chronic renal failure
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
1
Active Comparator
Vitrectomy
干预措施: Vitrectomy (Procedure)
2
Active Comparator
Intravitreal triamcinolone injections
干预措施: Intravitreal triamcinolone injections (Drug)
3
Active Comparator
Laser photocoagulation
干预措施: Laser photocoagulation (Procedure)
结局指标
主要结局
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years
时间窗: at 2 years
次要结局
- Central macular thickness on Optical Coherence Tomography (OCT)(at 8, 12 and 24 months)
- Percentage of patients with visual gain ≥ 3 ETDRS lines(8, 12 and 22 months)
- Progression of lens opacities(During the all follow-up)
- Frequency of complications(During the all follow-up)
- Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography(at inclusion time)
- Evolution of visual fiends and posterior vitreous detachment(At inclusion time and 2 years)
- Percentage of patients presenting an increase of 2 line or more of best corrected visual acuity on ETDRS charts(after 1 year, 22 months and 24 months of follow-up)
- Percentage of patients presenting an decrease of 2 line or more of best corrected visual acuity on ETDRS charts(after 1 year, 22 months and 24 months of follow-up)
- Scores ETDRS(after 1 year, 22 months and 24 months of follow-up)
- Mean best corrected visual acuity during follow-up period(during the all follow-up)
- Progression of retinopathy diabetic in each group(during the all follow-up)
- Outcome in respect to posterior vitreal detachment (PVD) stage(during the all follow-up)
- PVD stage evolution during the follow-yp in laser and triamcinolone group(first and last exam)
- Evolution of visual field in each group(inclusion and last visit)
研究者
研究点 (1)
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