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

• Status: Completed
• Trial end date: 2019-08-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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