Overview

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:

Participant gender:

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

Details

Lead Sponsor:

Centre Hospitalier Universitaire de Saint Etienne

Treatments:

BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate