A prospective, non-randomized, mono-center, cohort study to evaluate the effects of 0.5mg intraocular Ranibizumab (Lucentis) injections on retinal function in patients with diabetic macular edema (DME) during twelve months - Ranibizumab short- and long-term effects on retinal function in wAMD

niversitätsklinikum Schleswig-Holstein (UK-SH)0 个研究点开始时间: 2011年6月21日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•Diabetic macular edema with center involvement in at least one eye
•Patients with a central retinal thickness (CRT) > 250 µm
•Patients with a BCVA of 78-24 EDTRS letters
•Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
•Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
•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

•1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
•2. clinical or medical history uncontrolled hypertension or diabetes
•3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
•4. ventricular tachyarrythmias requiring ongoing treatment
•5. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
•6. Clinically significant impaired renal or hepatic function
•7. Stroke within 12 month before trial entry.
•8. Pregnancy
•9. Known serious allergies to the fluorescein dye use in angiography
•10. Known contraindications to the components of Lucentis® formulation.Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
•11. Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation

发起方

niversitätsklinikum Schleswig-Holstein (UK-SH)