NL-OMON37905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). - CRYSTA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female patients must be at least 18 years of age
- •2. Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein
- •occlusion (CRVO)
- •3. BCVA-sore 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)
排除标准
- •1. Stroke or myocardial infarction less than 3 months prior to Screening
- •2. 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
- •3. Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis,
- •keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye
- •4. 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
- •5. Neovascularization of the iris or neovascular glaucoma in either eye
- •6. Use of any systemic anti-vascular endothelial growth factor (VEGF) drugs within 6 months
- •prior to Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
- •7. 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®])
- •8. Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or
- •scheduled within the next 3 months following Baseline in the study eye
- •9. Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye
- •10. Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months prior to
- •Screening in the study eye
- •11. Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone
- •acetonide [Iluvien®]) in the study eye
研究者
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