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Treatment of the Bilateral Severe Uveitis by IVT of Regulator T-cells: Study of Tolerance of Dose (UVEREG)

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ClinicalTrials.gov Identifier: NCT02494492
Recruitment Status : Suspended
First Posted : July 10, 2015
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Uveitis is a leading cause of blindness in the children and young adult's populations. One third of etiology are idiopathic. The reference treatments are corticosteroids and immunosuppressive agents. They have significant side effects, and patient's compliance is often poor. In addition, some uveitis are more resistant. Also, in these situations of deadlock therapeutic, investigators propose a cell therapy by administering regulatory T cells (Tregs) in the vitreous of patients.

Condition or disease Intervention/treatment Phase
Uveitis Other: intravitreous administration of regulator T-cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of the Bilateral Severe Uveitis by IVT of Regulator T-cells: Study of Tolerance of Dose
Study Start Date : March 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arm Intervention/treatment
Experimental: IVT of regulator T-cells
intravitreous administration of regulator T-cells
Other: intravitreous administration of regulator T-cells
The 3 levels of Tregs doses will be respectively 0.4, 1.2 and 3.6 million.
Other Name: cell therapy




Primary Outcome Measures :
  1. Toxicity (occurrence of at least 2 ocular serious adverse events) [ Time Frame: 4 weeks ]

    Toxicity (or intolerance) is defined as the occurrence of at least 2 ocular serious adverse events in 4 weeks following the injection of

    Treg, defined as:

    • an increase on OCT of the retinal thickness of <800mm from the initial review of the visit 1 of the eye injected,
    • decrease in visual acuity compared to the initial review of the visit 1of the eye injected with 2 lines,
    • occurence of ocular hypertension uncontrolled by ≥ 21 mmHg local treatment or hypotonia (5mmHg) compared to the initial review of the visit 1 of the eye injected,
    • occurence of vitreous hemorrhage, retinal necrosis, except complications attributed to the technique of administration,
    • onset of a hypopyon, except complication attributed to the technical Board


Secondary Outcome Measures :
  1. ETDRS scale [ Time Frame: 4 weeks ]
    visual acuity measured by ETDRS scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects ≥ 18 years
  • severe bilateral uveitis not infectious
  • visual acuity between CLD and 1/10 for the eye the most affected and less than 5/10 for the fellow eye
  • failed steroid ≤ 15 mg / day with or without an immunosuppressive agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494492


Locations
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France
Department of ophthalmology Groupe Hospitalier Pitié-Salpêtrière - Charles FOIX
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Bahram BODAGHI, Professor Assitance publique - Hopitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02494492    
Other Study ID Numbers: P081250
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Uveitis
Lymphocyte cells
lymphocyte T regulator
vitreous haze
intravitreal injection
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases