NCT00562406已完成不适用
Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
Klinikum Ludwigshafen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in best spectacle-corrected visual acuity (BSCVA)
研究概览
简要总结
The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.
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
- •Adults aged 18 years and older with chronic (> 3months, < 18 months) macular edema secondary to branch retinal vein occlusion
- •Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters
- •Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography:
- •Evidence that the macular edema extends under the geometric center of the foveal avascular zone.
- •Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis).
- •Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3):
- •Evidence that central macular thickness is > 225 μm.
- •Ability of subject to understand character and individual consequences of clinical trial.
- •Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
- •For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study).
- •Only one eye of a patient may be included to this trial.
排除标准
- •Patients who at baseline
- •Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others)
- •Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies)
- •Had previous treatment for macular edema (laser, triamcinolone, vitrectomy)
- •Pregnancy and lactation.
- •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- •Participation in other clinical trials within the last 3 months.
- •Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
- •Arterial hypertension refractory to medical treatment
研究组 & 干预措施
1
Active Comparator
laser photocoagulation to the retina at the area of edema
干预措施: Laser photocoagulation (Procedure)
2
Experimental
intravitreal injection of ranibizumab
干预措施: Ranibizumab (Drug)
2
Experimental
intravitreal injection of ranibizumab
干预措施: Laser photocoagulation (Procedure)
3
Experimental
laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Changes in best spectacle-corrected visual acuity (BSCVA)
时间窗: from baseline to month 6
次要结局
- Mean change in BSCVA(from baseline to month 3)
- Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA(from baseline to month 3 and 6)
- Proportion of patients who lose less than 15 letters of BCVA(from baseline to month 3 and 6)
- Change in area and intensity of leakage(from baseline to month 1, 3 and 6)
- Mean change in central macular thickness (by OCT)(from month 3 to 6)
研究者
研究点 (1)
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