Safety study of stem cell injection for non arteritic anterior ischemic optic neuropathy

Phase 1

• Conditions: on arteritic anterior ischemic optic neuropathy (NAION); Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-003029-40-ES
• Lead Sponsor: IOBA - University of Valladolid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-09
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of the safety of Intravitreal mesenchymal stem cells in patients with Non arteritic anterior ischemic optic neuropathy (NAION) in the acute fase;Secondary Objective: Not applicable;Primary end point(s): Main safety variable is defined by all of the following assessments. Any finding from the list means failure :<br><br>- >1+ cells in anterior chamber<br>- >1+ flare in anterior chamber<br>- > 2+ vitreous flare<br><br>All these items are graded following the SUN (standardization of uveitis nomenclature) scale;Timepoint(s) of evaluation of this end point: At every scheduled visit after treatment, and at any unscheduled visit that any patient might need

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Adverse events procedure-related (intravitreal injection): conjunctival haemorrhages, anterior chamber inflammation, changes in intraocular pressure, infectious endotphthalmitis, vitreous inflammmation (cells or opacities), retinal detachment, choroidal detachment, corneal opacities, lens opacities, neovascularization, macular edema or any other adverse event that may appear.<br><br>- Adverse events<br><br>- Changes in best corrected visual acuity (BCVA) or ocular electrophysiology tests;Timepoint(s) of evaluation of this end point: At every scheduled visit after treatment, and at any unscheduled visit that any patient might need