CTRI/2019/03/018322进行中（未招募）3 期
A Prospective, Randomized, Parallel Group, Double Blind, Multicenter Study to Compare the Efficacy, Safety & Immunogenicity of Lupinâ��s Ranibizumab with Lucentis�® in Patients with Neovascular Age-Related Macular Degeneration
upin Limited Biotechnology Division0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 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
入排标准
入选标准
- •1.Ambulatory male or female participants with age ââ?°Â¥ 50 years at the time of screening who are capable of understanding and giving written informed consent.
- •2.Primary or recurrent active choroidal neovascularization (CNV) lesions involving the foveal centre secondary to age-related macular degeneration in any one of the eye. (If both eyes are affected and eligible patient and study ophthalmologist will select one eye for study purpose).
- •3.Best corrected visual acuity in the study eye using ETDRS testing between 20/ 40 and 20/ 320 (Snellen equivalent) both inclusive before pupil dilation.
- •4.Females who are of non-child bearing potential (surgically sterile or menopausal) OR if of child bearing potential using effective birth control and non-pregnant & non-lactating.
排除标准
- •Patients who meet any of the following criteria should be disqualified from entering the study:
- •1.Known hypersensitivity to ranibizumab or any of the components of study medication.
- •2.Allergy to fluorescein dye.
- •3.Patients with coexisting CNV lesions secondary to AMD in the non-study eye that would require simultaneous treatment with anti-VEGF therapies during the study period.
- •Ocular Conditions of the study eye:
- •4.Any other pathology involving the CNV lesion like retrofoveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50 % of lesion area of study eye that can affect the efficacy of drug.
- •5.Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or 4) in the study eye.
- •6.Aphakia or absence of the posterior capsule in the study eye.
- •7.Uncontrolled glaucoma as evident by progressive damage to optic nerve or visual fields despite optimum therapy; or steroid-induced glaucoma with continued use of steroids that requires IOP-lowering treatment.
- •8.H/o serious complications following surgery in the study eye within 1 year prior to randomization.
- •Concomitant Medications/ Treatments & Procedures:
- •9.Previous treatment with intravenous Bevacizumab (AvastinÃ?®), or intravitreal Ranibizumab (LucentisÃ?®), Bevacizumab (AvastinÃ?®), Aflibercept (EyleaÃ?®), Pegaptanib (MacugenÃ?®) in either of the eyes.
- •10.Previous external beam radiation or subfoveal focal laser photocoagulation/ thermal laser or transpupillary thermotherapy in the study eye within 5 years prior to randomization.
- •11.Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or other AMD therapy in the study eye within 3 months prior to randomization.
- •12.Previous treatment with intravitreal ocular or periocular steroids (e.g., triamcinolone, anecortave acetate) or intravitreal or peribulbar steroid in the study eye within past 3 months.
- •13.Concurrent use of systemic anti-VEGF agents.
- •14.History of vitrectomy, submacular surgery or other surgical intervention for AMD, corneal transplant or any device implantation in the study eye.
- •15.Intraocular surgery (including cataract surgery) in the study eye within 2 months prior to randomization.
- •16.Concurrent treatment with an investigational drug or device in the non-study eye.
- •17.Previous participation in any studies of investigational drugs within 30 days or as prescribed in that study (whichever is later) preceding the initial study treatment.
- •Other Ocular Conditions:
- •18.CNV in the study eye due to causes other than AMD such as histoplasmosis, trauma, or pathological myopia etc. or CNV lesion not likely to respond to ranibizumab.
- •19.Active or ongoing ocular infection (e.g. infectious conjunctivitis, keratitis, scleritis, or endophthalmitis) or severe inflammation in either of the eyes.
- •20.Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 3 month study period or that could contribute to a loss (of at least 2 Snellen equivalent lines) of best corrected visual acuity ove
研究者
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