Phase II Safety Assessment of Intravitreal Injection of Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale
研究概览
简要总结
In this study the investigators propose to perform a Phase II Clinical Trial which seeks to evaluate the safety of cell therapy as a new treatment for patients who suffer from acute non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study to assess efficacy will be performed.
This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results in blindness. Currently, there is no available treatment and second eye involvement occurs in approximately 15-25% of the cases.
All this background originates a particularly dramatic outcome for the patient. Therefore, it seems justified to evaluate new therapies that maintain or improve the visual function in these patients.
The Project includes a clinical trial whose purpose is the assessment of the safety of intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION, a product in clinical research phase (PEI No. 15-007) already approved for other human clinical applications (PEI No. 15-007).
It can be considered that the therapy with intravitreal injection of MSC is a treatment option in patients with acute NAION, since through the paracrine properties of these cells (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or reduce the progression of axonal degeneration caused by this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following:
- •Sudden and unpainful monocular vision loss
- •Visual field defects
- •Dyschromatopsia.
- •Ocular nerve head edema.
- •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 pupil sphincter muscle motility
- •Signed informed consent form before any study procedure.
- •Signed data protection consent form before any study procedure.
排除标准
- •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, collagenopathies or previous cancer treatments.
- •Hypersensitivity or allergy to any compound used in the study, including investigational medicinal product (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 evidence 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
结局指标
主要结局
Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale
时间窗: Changes compared to baseline in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need
Following the SUN scale, the parameters that will be taken into account in the slit lamp exploration will be: cells and flare in anterior chamber, and vitreous flare
次要结局
- Adverse events procedure-related (intravitreal injection)(Throughout the study after treatment in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need)