Clinical trial NCT02834260: Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study
Official title: Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconus
Fuchs' Endothelial Dystrophy
Congenital Hereditary Stromal Dystrophy of the Cornea
Keywords: absorbable implant
subconjunctival
immune rejection
safety profile
dexamethasone
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: intraocular pressure
timeFrame: one month post graft
Secondary outcomes:
measure: Score of ocular discomfort
timeFrame: 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
measure: Ocular redness
timeFrame: 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
measure: Rejection episodes
timeFrame: 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
measure: Graft thickness
timeFrame: one month post graft
measure: Patient requiring dexamethasone eyedrops
timeFrame: one month post graft
measure: Date of disappearance of the implant
timeFrame: up to 1 year
measure: intraocular pressure
timeFrame: 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
measure: presence of hemorrhage
timeFrame: 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
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Marie Caroline TRONE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trone MC, Poinard S, Crouzet E, Garcin T, Mentek M, Forest F, Matray M, Thuret G, Gain P. Dropless penetrating keratoplasty using a subconjunctival dexamethasone implant: safety pilot study. Br J Ophthalmol. 2023 Feb;107(2):181-186. doi: 10.1136/bjophthalmol-2021-319376. Epub 2021 Aug 23.