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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 2

Conditions: Keratoconus; Fuchs' Endothelial Dystrophy; Congenital Hereditary Stromal Dystrophy of the Cornea

Treatments: Drug: Dexamethasone implant OZURDEX

Study type: Interventional

Funder types: Other

Identifiers

NCT02834260

1608042

2016-001168-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

ozurdex group

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone implant OZURDEX