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

NCT02494492 | Suspended Phase 1 DMC

• 1 other identifier: P081250
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis

Keywords

Uveitis; Lymphocyte cells; lymphocyte T regulator; vitreous haze; intravitreal injection

Outcome Measures

Primary Outcomes (1)

• Toxicity (occurrence of at least 2 ocular serious adverse events)

  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

  4 weeks

Secondary Outcomes (1)

• ETDRS scale

  4 weeks

Study Arms (1)

IVT of regulator T-cells

EXPERIMENTAL

intravitreous administration of regulator T-cells

Other: intravitreous administration of regulator T-cells

Interventions

intravitreous administration of regulator T-cells OTHER

The 3 levels of Tregs doses will be respectively 0.4, 1.2 and 3.6 million.

Also known as: cell therapy

IVT of regulator T-cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of ophthalmology Groupe Hospitalier Pitié-Salpêtrière - Charles FOIX

Paris, 75013, France

Location

MeSH Terms

Conditions

Uveitis

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Bahram BODAGHI, Professor

  Assitance publique - Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: July 10, 2015
• Study Start: March 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

FR (1)