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Clinical Trials/EUCTR2016-003029-40-ES
EUCTR2016-003029-40-ES
Active, not recruiting
Phase 1

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

IOBA - University of Valladolid0 sitesDecember 9, 2016
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Conditionson arteritic anterior ischemic optic neuropathy (NAION)Therapeutic area: Diseases [C] - Eye Diseases [C11]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
on arteritic anterior ischemic optic neuropathy (NAION)
Sponsor
IOBA - University of Valladolid
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 9, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IOBA - University of Valladolid

Eligibility Criteria

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

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).

Outcomes

Primary Outcomes

Not specified

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