Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02834260
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
Official Title:
Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEXACOR
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-001168-12 | EUDRACT_NUMBER | None | View |