EUCTR2006-006131-53-DE进行中（未招募）不适用
Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study - RABAMES
Society (institute) for clinical research0 个研究点开始时间: 2007年1月2日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adults aged 18 years and older with chronic (>3 months, <18 months) macular edema secondary to branch retinal vein occlusion
- •Patients who at baseline have a best spectacle-corrected visual acuity (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:
- •o Evidence that the macular edema extends under the geometric center of the
- •foveal avascular zone.
- •o 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):
- •o 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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who at baseline
- •o 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)
- •o have a relevant systemic disease which may be associated with increased
- •systemic VEGF levels (namely all malignancies)
- •o 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.
研究者
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