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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Dexamethasone implant OZURDEX
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keratoconus focused on measuring absorbable implant, subconjunctival, immune rejection, safety profile, dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ozurdex group

Arm Description

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.

Outcomes

Primary Outcome Measures

intraocular pressure

Secondary Outcome Measures

Score of ocular discomfort
analogic visual scale
Ocular redness
digital picture
Rejection episodes
Graft thickness
Patient requiring dexamethasone eyedrops
Date of disappearance of the implant
intraocular pressure
presence of hemorrhage
with tomography

Full Information

First Posted
July 8, 2016
Last Updated
August 14, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02834260
Brief Title
Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study
Acronym
IDEXACOR
Official Title
Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Fuchs' Endothelial Dystrophy, Congenital Hereditary Stromal Dystrophy of the Cornea
Keywords
absorbable implant, subconjunctival, immune rejection, safety profile, dexamethasone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ozurdex group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone implant OZURDEX
Primary Outcome Measure Information:
Title
intraocular pressure
Time Frame
one month post graft
Secondary Outcome Measure Information:
Title
Score of ocular discomfort
Description
analogic visual scale
Time Frame
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
Title
Ocular redness
Description
digital picture
Time Frame
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
Title
Rejection episodes
Time Frame
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
Title
Graft thickness
Time Frame
one month post graft
Title
Patient requiring dexamethasone eyedrops
Time Frame
one month post graft
Title
Date of disappearance of the implant
Time Frame
up to 1 year
Title
intraocular pressure
Time Frame
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
Title
presence of hemorrhage
Description
with tomography
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Caroline TRONE, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34426402
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.
Results Reference
derived

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

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