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Completed

NCT Number: NCT02834260

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

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.

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Key information

Conditions

Keratoconus Congenital Hereditary Stromal Dystrophy of the Cornea Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Dystrophy, Congenital Stromal Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone implant OZURDEX

Drug

Primary outcomes

  1. intraocular pressure

    Time frame: one month post graft

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: IDEXACOR

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 15, 2016
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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