Phase II safety assessment of intravitreal injection of mesenchymal stem cells for acute non arteritic anterior ischemic optic neuropathy (NAION)

IOBA - University of Valladolid0 个研究点开始时间: 2016年12月9日最近更新: 2017年2月20日

适应症

试验速览

暂无简介。

•Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following:
•a) Sudden and unpainful monocular vision loss
•b) Visual field defects
•c) Dyschromatopsia.
•d) Ocular nerve head edema.
•e)Afferent relative pupil defect.
•- Patients = 50 years old, able to freely give informed consent.
•- Best corrected visual acuity (BCVA) = 0,1 in study eye.
•- Pseudophakia in study eye.
•- Preserved pupilas sphyncter muscle motility
•- Signed informed consent form before any study procedure.
•- Signed data protection consent form before any study procedure.
•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 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•General exclusion criteria
•- Giant cell arteritis evidence (clinical history, Erythrocyte sedimentation rate (ESR), C-Reactive Protein)
•- Evidence of any other etiology that may justify the optic neuropathy (even in the non-study eye)
•- History of systemic vasculitis, multiple sclerosis, colagenopathies or previous cancer treatments.
•- Hipersensitivity or allergy to any compound used in the study, including IMP.
•- Positive pregnancy test at baseline
•- Participation in any other research study within 2 months
•Ophthalmic exclusion criteria
•- History of uveitis or active ocular inflammation
•- History or evidente of glaucoma or high intraocular pressure ( = 24 mmHg in either eye).
•- Mean opacities or retinal pathologies in the study eye.
•- Any previous vitreous or glaucoma surgery in the study eye
•-Cataract surgery within 3 months in the study eye

发起方

IOBA - University of Valladolid