EUCTR2011-002350-31-HU
进行中（未招募）
不适用
A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven PRN dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) - CRYSTA
适应症visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)MedDRA version: 14.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.0Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.0Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
相关药物LUCENTIS
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- •\- Written informed consent must be obtained before any study assessment is performed\- Male or female patients must be at least 18 years of age
- •\- Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein occlusion (CRVO)
- •\- Best\-corrected visual acuity at Screening and Baseline must be between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400\)
- •Other protocol\-defined inclusion criteria may apply
- •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
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
- •Stroke or myocardial infarction less than 3 months prior to Screening
- •Uncontrolled blood pressure defined as systolic value of \>160 mm Hg or diastolic value of \>100 mm Hg at Screening or Baseline. Antihypertensive treatment can be initiated and has to be taken for at least 30 days after which the patient can be assessed for study eligibility a second time
- •Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye
- •Uncontrolled glaucoma (intraocular pressure \[IOP] \=30 mm Hg on medication or according to investigator’s judgment) at Screening or Baseline or diagnosed within 6 months prior to Baseline in either eye
- •Neovascularization of the iris or neovascular glaucoma in either eye
- •Use of any systemic anti\-vascular endothelial growth factor (VEGF) drugs within 6 months prior to Baseline (eg, sorafenib \[Nexavar®], sunitinib \[Sutent®], bevacizumab \[Avastin®])
- •Prior treatment with any anti\-angiogenic drugs (including any anti\-VEGF agents) within 3 months prior to Baseline in either eye (eg, pegaptanib \[Macugen®], ranibizumab \[Lucentis®], bevacizumab \[Avastin®])
- •Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
- •Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye
研究者
相似试验
进行中（未招募）
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Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eyeEUCTR2011-002350-31-CZovartis Pharma Services AG350
进行中（未招募）
不适用
Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eyevisual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)MedDRA version: 14.1Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2011-002350-31-DKovartis Pharma Services AG350
进行中（未招募）
不适用
Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eyevisual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)MedDRA version: 15.0Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 15.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 15.0Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2011-002350-31-PLovartis Pharma Services AG350
已完成
3 期
A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven pro re rata (PRN) dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).visual impairment10047060NL-OMON37905ovartis25
进行中（未招募）
不适用
Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eyevisual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)MedDRA version: 18.0Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2011-002350-31-PTovartis Pharma Services AG350