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

Keratoconus Clinical Trial

— IDEXACOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834260
• Other study ID #: 1608042
• Secondary ID: 2016-001168-12
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2017
• Est. completion date: August 8, 2019

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 8, 2019
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hereditary Stromal Dystrophy of the Cornea
• Corneal Dystrophies, Hereditary
• Fuchs' Endothelial Dystrophy
• Keratoconus

Intervention

Drug:
• Dexamethasone implant OZURDEX

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure		one month post graft
Secondary	Score of ocular discomfort	analogic visual scale	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
Secondary	Ocular redness	digital picture	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
Secondary	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
Secondary	Graft thickness		one month post graft
Secondary	Patient requiring dexamethasone eyedrops		one month post graft
Secondary	Date of disappearance of the implant		up to 1 year
Secondary	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
Secondary	presence of hemorrhage	with tomography	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