NCT02834260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

August 16, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

July 8, 2016

Last Update Submit

August 14, 2019

Conditions

KeratoconusFuchs' Endothelial DystrophyCongenital Hereditary Stromal Dystrophy of the Cornea

Keywords

absorbable implantsubconjunctivalimmune rejectionsafety profiledexamethasone

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    one month post graft

Secondary Outcomes (8)

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (1)

ozurdex group

EXPERIMENTAL

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

Interventions

Dexamethasone implant OZURDEXDRUG
ozurdex group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Keratoconus
  • Fuch's dystrophy
  • Hereditary stromal dystrophy
  • Age 18 years old and more
  • Signed informed consent
  • Affiliated to the French Social Security

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • 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.

    PMID: 34426402DERIVED

MeSH Terms

Conditions

KeratoconusFuchs' Endothelial DystrophyCorneal Dystrophy, Congenital Stromal

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesCorneal Dystrophies, HereditaryEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marie Caroline TRONE, MD

    Centre Hospitalier Universitaire de Saint Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 15, 2016

Study Start

January 10, 2017

Primary Completion

August 28, 2018

Study Completion

August 8, 2019

Last Updated

August 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)