A 12-month, randomized, double-masked, sham-controlled, multicenterstudy to evaluate the efficacy and safety of 0.5 mg ranibizumab intravitrealinjections in patients with visual impairment due to vascular endothelialgrowth factor (VEGF) driven macular edema (ME)

ovartis Farmacéutica, S.A.0 个研究点目标入组 187 人开始时间: 2013年6月24日最近更新: 2015年10月12日

适应症

试验速览

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•1. Diagnosis of treatment naïve (patient has not received any prior medication/ treatment for the ME lesion under study) active ME secondary to any causes (for adult patients: except DME and RVO);
•2. BCVA must be between ? 24 and ? 83 letters tested at 4 meters starting distance using ETDRS-like visual acuity charts;
•3. Visual loss should be only due to the presence of any eligible types of ME based on ocular clinical, as well as FA and OCT findings.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 157
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment;
•2. History of malignancy of any organ system within the past 5 years;
•3. History of stroke less than 6 months prior to screening;
•4. Active systemic inflammation or infection, related directly to the underlying causal disease of ME at screening;
•5. Active diabetic retinopathy, active ocular/periocular infectious disease or active intraocular inflammation at screening;
•6. Confirmed intraocular pressure (IOP) ? 25 mmHg for any reason at screening;
•7. Neovascularization of the iris or neovascular glaucoma at screening;
•8. ME secondary to DME or RVO (for adult patients only);
•9. Use of any systemic anti-VEGF drugs within 6 months before baseline;
•10. History of focal/grid laser photocoagulation with involvement of the macular area administered to treat ME at any time;
•11. History of intraocular treatment with any anti-angiogenic drugs (including any anti-VEGF agents) or verteporfin photodynamic therapy
•(vPDT) at any time; 12. History of intravitreal treatment with corticosteroids at any time;
•13. History of vitreoretinal surgery at any time. Other protocol-defined inclusion/exclusion criteria may apply.

发起方

ovartis Farmacéutica, S.A.