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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02834260

Collaborator

(none)

Enrollment

Location

Arm

30.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus Fuchs' Endothelial Dystrophy Congenital Hereditary Stromal Dystrophy of the Cornea	Drug: Dexamethasone implant OZURDEX	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 10, 2017

Actual Primary Completion Date :

Aug 28, 2018

Actual Study Completion Date :

Aug 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ozurdex group 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.	Drug: Dexamethasone implant OZURDEX

Arm

Intervention/Treatment

Experimental: ozurdex group

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.

Drug: Dexamethasone implant OZURDEX

Outcome Measures

Primary Outcome Measures

intraocular pressure [one month post graft]

Secondary Outcome Measures

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]
Graft thickness [one month post graft]
Patient requiring dexamethasone eyedrops [one month post graft]
Date of disappearance of the implant [up to 1 year]
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]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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