Assessment of the suitability of serum VEGF level as diagnostic factor in macula edema caused by retinal or central retinal vein occlusion under therapy with Lucentis® (ranibizumab)

Prof. Dr. Karl-Heinz Emmerich0 个研究点目标入组 30 人开始时间: 2014年11月18日最近更新: 2018年2月5日

适应症

试验速览

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•- Signed and dated Informed Consent prior to conduct of any study-related procedure
•- Adult patient aged 18 years or more with the diagnosis of a decrease in visual acuity due to macula edema as a consequence of central retinal or retinal vein occlusion maximum 12 months prior to screening
•- Central retinal thickness (CRT) > 250 µm
•- Clear breaking media, possibility for good mydriasis and good cooperation of the patient in case of fundus photography
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- Central retinal thickness = 250 µm
•- Previous episode(s) of retinal vein occlusion at the study eye
•- Active neovascularisation
•- Aphakia of study eye (pseudo-aphake eyes are allowed)
•- History of thrombotic or embolic disease
•- Every history of a apoplectic insult or a transitory ischemic attack (TIA)
•- Ocular or systemic anti-VEGF-treatment in the three months prior to screening
•- History of pars plana vitrectomy
•- Combined arterio-venuous occlusion
•- Intraocular intervention within the 2 months prior to screening or planned intraocular intervention in the 12 months after screening
•- Known vitreoretinal diseases,
•- Intraocular pressure = 30 mm or uncontrolled glaucoma
•- Every active infection at one of the two eyes
•- Every ocular disease which in the opinion of the investigator would distort the study results
•- Every relevant ocular disease which could affect the increase of the intraocular VEGF level
•- Every relevant systemic disease which could potentially lead to an increase of the systemic VEGF level
•- Known hyper sensivity or allergy to the study medication or any medication needed for diagnosis/therapy
•- Diseases or conditions which in the opinion of the investigator exclude a subject's participation in the trial
•- Participation in another clinical or non-intverventional study

发起方

Prof. Dr. Karl-Heinz Emmerich