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Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study (IDEXACOR)

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ClinicalTrials.gov Identifier: NCT02834260
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and constitute one of the main factors reducing graft survival. They mainly occur during the first 18 months. Prevention usually relies on a topical treatment with dexamethasone or prednisolone for standard risk patients. Eye drops are instilled three times a day during at least 3 months then tapered.

OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone during several months. It is indicated for intravitreal injection to treat macular edema.

The investigators hypothesized that this implant could be used after subconjunctival injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop instillations.


Condition or disease Intervention/treatment Phase
Keratoconus Fuchs' Endothelial Dystrophy Congenital Hereditary Stromal Dystrophy of the Cornea Drug: Dexamethasone implant OZURDEX Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: ozurdex group
Subconjunctival injection of the absorbable implant of Dexamethasone immediately at the end of penetrating keratoplasty. The injection is made at the 12 O'Clock position is a bubble created by subconjunctival injection of balanced salt solution.
Drug: Dexamethasone implant OZURDEX



Primary Outcome Measures :
  1. intraocular pressure [ Time Frame: one month post graft ]

Secondary Outcome Measures :
  1. Score of ocular discomfort [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
    analogic visual scale

  2. Ocular redness [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
    digital picture

  3. Rejection episodes [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
  4. Graft thickness [ Time Frame: one month post graft ]
  5. Patient requiring dexamethasone eyedrops [ Time Frame: one month post graft ]
  6. Date of disappearance of the implant [ Time Frame: up to 1 year ]
  7. intraocular pressure [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
  8. presence of hemorrhage [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
    with tomography



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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:

  • Keratoconus
  • Fuch's dystrophy
  • Hereditary stromal dystrophy
  • Age 18 years old and more
  • Signed informed consent
  • Affiliated to the French Social Security

Exclusion Criteria:

  • Hypersensitivity to Dexamethasone or the excipients (polylactic and glycolic acid)
  • Active ocular or periocular infection
  • Advanced glaucoma
  • History of herpetic or zoster keratitis
  • Retinal disease for which an intravitreal injection of Ozurdex is planed for the next 3-4 months

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): NCT02834260


Contacts
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Contact: Marie Caroline TRONE, MD (0)4 77 12 70 12 ext +33 m.caroline.trone@chu-st-etienne.fr
Contact: Carine LABRUYERE (0)4 77 12 04 69 ext +33 carine.labruyere@chu-st-etienne.fr

Locations
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France
CHU de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Marie Caroline TRONE, MD    (0)4 77 12 70 12 ext +33    m.caroline.trone@chu-st-etienne.fr   
Principal Investigator: Marie Caroline TRONE, MD         
Sub-Investigator: Philippe GAIN, MD PhD         
Sub-Investigator: Claire GUILLEMOT, MD         
Sub-Investigator: Rémy JULLIENNE, MD         
Sub-Investigator: Gilles THURET, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Marie Caroline TRONE, MD Centre Hospitalier Universitaire de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02834260     History of Changes
Other Study ID Numbers: 1608042
2016-001168-12 ( EudraCT Number )
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
absorbable implant
subconjunctival
immune rejection
safety profile
dexamethasone

Additional relevant MeSH terms:
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Keratoconus
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action