A Prospective, Multicenter Clinical Study to Assess Safety, Immunogenicity and Efficacy of Ranibizumab (Intas Pharmaceuticals Limited) for the Treatment of Wet AMD (Age Related Macular Degeneration)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 19
- 主要终点
- •Percentage of patients developing anti-Ranibizumab antibody after 6
研究概览
简要总结
Age-related macular degeneration (AMD) is one of the leading causes ofsubstantial and irreversible vision loss. Without treatment, the neovascular form of AMDleads to severe quality-of-life loss within a short time period andconsiderable economic burden. The Food and DrugAdministration (FDA) approved ranibizumab for treatment of subfovealneovascular AMD in June, 2006. It was the first treatment for AMD shown toimprove visual acuity in a substantial percentage of patients. Intas’formulation of Ranibizumab has been approved by the Indian drug authority forsale in Indian market. Marketing authorisation in India was obtained followingsubmission of the results of a comparative efficacy and safety study withNovartis’ Reference product in 104 adult patients of wet AMD receiving 0.5 mgintravitreally every 4 weeks for 12 weeks duration. The proposed study is beingundertaken to generate additional safety, immunogenicity and efficacy data ofIntas ranibizumab for the treatment of wet AMD in adult patients aged ≥50years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 50.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female participant with age ≥ 50 years at the time of screening
- •Active primary or recurrent subfoveal lesion with CNV(choroidal neovascularization) secondary to AMD, involving the foveal center
- •Have a best corrected visual acuity of 20/40 to 20/320 using Early Treatment Diabetic Retinopathy Study chart- ETDRS (Snellen equivalent) in the study eye.
- •(Only one eye will be assessed in the study.
- •If both eyes are eligible, the one with the better visual acuity is selected for treatment and study unless, based on medical reasons, the investigator deemed the other eye the more appropriate candidate for treatment and study).
- •Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
排除标准
- •1.Prior treatment with any intravitreal drug, verteporfin or photodynamic therapy in the study eye and/or non study eye within past 3 months before study entry 2.Extrafoveal Laser photocoagulation within 1 month before study entry in the study eye 3.Prior treatment with systemic or intravitreal bevacizumab therapy within last 6 months 4.Subfoveal fibrosis or atrophy in the study eye 5.CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia etc 6.Retinal pigment epithelial tear involving the macula in the study eye 7.Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 6 month study period or that could contribute to a loss of best corrected visual acuity over the 6 months study period 8.Active intraocular inflammation or ongoing infection in the study eye 9.Vitreous hemorrhage in the study eye or history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye 10.Any other retinal pathology i.e. CRVO, CRAO etc.
- •11.Known hypersensitivity to ranibizumab or any of the components of study medication 12.Previous participation in any clinical trial within 1 month before the entry of the study 13.Any other condition that in the opinion of investigator could hamper participation in the study.
结局指标
主要结局
•Percentage of patients developing anti-Ranibizumab antibody after 6
时间窗: Baseline to week 24
•Incidence of adverse events (AEs) and serious adverse events (SAEs
时间窗: Baseline to week 24
including any hypersensitivity reactions and significant laboratory
时间窗: Baseline to week 24
abnormalities
时间窗: Baseline to week 24
months of treatment.
时间窗: Baseline to week 24
次要结局
- To assess efficacy of investigational medicinal product in adult patients with wet-AMD.(At the end of study (week 24))