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

Phase 2

Completed

• Conditions: Keratoconus; Fuchs' Endothelial Dystrophy; Congenital Hereditary Stromal Dystrophy of the Cornea
• Interventions: Drug: Dexamethasone implant OZURDEX

• Registration Number: NCT02834260
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-15
• Study Start: 2017-01-10
• Primary Completion: 2018-08-28
• Status Verified: 2019-05
• Study Completion: 2019-08-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ozurdex group	Dexamethasone implant OZURDEX	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.

Primary Outcome Measures

Name	Time	Method
intraocular pressure	one month post graft

Secondary Outcome Measures

Name	Time	Method
Graft thickness	one month post graft
Patient requiring dexamethasone eyedrops	one month post graft
Score of ocular discomfort	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
Ocular redness	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
Rejection episodes	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
Date of disappearance of the implant	up to 1 year
presence of hemorrhage	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
intraocular pressure	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

Trial Locations

Locations (1)

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France