Safety Assessment of Intravitreal Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Arteritic Ischemic Optic Neuropathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following: 1. Sudden and unpainful monocular vision loss 2. Visual field defects 3. Dyschromatopsia. 4. Ocular nerve head edema. 5. 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. 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, 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

Outcomes

Primary Outcomes

Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale

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

Time frame: 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

Secondary Outcomes

Adverse events procedure-related (intravitreal injection)

Conjunctival haemorrhages, anterior chamber inflammation, changes in intraocular pressure, infectious endophthalmitis, vitreous inflammation, retinal detachment, choroidal detachment, corneal opacities, lens opacities, neovascularization, macular edema or any other adverse event that may appear

Time frame: 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