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Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

Primary Purpose

Fuchs' Dystrophy, Bullous Keratopathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Prednisolone acetate
Fluorometholone
Sponsored by
Price Vision Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fuchs' Dystrophy focused on measuring DMEK, Rejection, Corticosteroid

Eligibility Criteria

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

INCLUSION CRITERIA: The following are requirements for inclusion in the study:

  • Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 7 weeks
  • Patient is able and willing to administer eye drops.
  • Patient is able to comprehend and has signed the Informed Consent form.
  • Patient is likely to complete the entire one-year course of the study.
  • Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye.
  • Corneal neovascularization will not be judged as an exclusion criteria for the study

EXCLUSION CRITERIA: The following are exclusion criteria for patients in this study:

  • A patient with a previous failed graft in the study eye with a history of a prior rejection episode
  • A patient exhibiting any intraocular inflammation
  • A patient with a known sensitivity to any of the ingredients in the study medications
  • A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
  • A patient with abnormal eyelid function
  • A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis
  • A patient with the presence of any ocular disease that would interfere with the evaluation of the study treatment
  • A patient with a history of non-compliance with using prescribed medication
  • A patient who is concurrently involved in or participated in another clinical trial within 30 days prior to enrollment in this study.

Sites / Locations

  • Price Vision Group
  • University of Erlangen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fluorometholone 0.1% Solution

Prednisolone acetate 1% Solution

Arm Description

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Outcomes

Primary Outcome Measures

Number of Eyes With Immunologic Graft Rejection Episodes

Secondary Outcome Measures

Number of Eyes With Intraocular Pressure (IOP) Elevation
Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.

Full Information

First Posted
October 4, 2011
Last Updated
August 22, 2014
Sponsor
Price Vision Group
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1. Study Identification

Unique Protocol Identification Number
NCT01448213
Brief Title
Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
Official Title
Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Price Vision Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.
Detailed Description
Graft rejection is one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used after transplant surgery. The steroid eye drop dosing regimen varies from surgeon to surgeon, because no studies have been done to determine the optimum dosing regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Dystrophy, Bullous Keratopathy
Keywords
DMEK, Rejection, Corticosteroid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluorometholone 0.1% Solution
Arm Type
Active Comparator
Arm Description
Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Arm Title
Prednisolone acetate 1% Solution
Arm Type
Active Comparator
Arm Description
Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Intervention Type
Drug
Intervention Name(s)
Prednisolone acetate
Intervention Description
Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Intervention Type
Drug
Intervention Name(s)
Fluorometholone
Intervention Description
Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Primary Outcome Measure Information:
Title
Number of Eyes With Immunologic Graft Rejection Episodes
Time Frame
Within 1 year
Secondary Outcome Measure Information:
Title
Number of Eyes With Intraocular Pressure (IOP) Elevation
Description
Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.
Time Frame
one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: The following are requirements for inclusion in the study: Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 7 weeks Patient is able and willing to administer eye drops. Patient is able to comprehend and has signed the Informed Consent form. Patient is likely to complete the entire one-year course of the study. Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye. Corneal neovascularization will not be judged as an exclusion criteria for the study EXCLUSION CRITERIA: The following are exclusion criteria for patients in this study: A patient with a previous failed graft in the study eye with a history of a prior rejection episode A patient exhibiting any intraocular inflammation A patient with a known sensitivity to any of the ingredients in the study medications A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study A patient with abnormal eyelid function A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis A patient with the presence of any ocular disease that would interfere with the evaluation of the study treatment A patient with a history of non-compliance with using prescribed medication A patient who is concurrently involved in or participated in another clinical trial within 30 days prior to enrollment in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Friedrich Kruse, MD
Organizational Affiliation
University of Erlangen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Erlangen
City
Erlangen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25062336
Citation
Price MO, Price FW Jr, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty. Cornea. 2014 Sep;33(9):880-6. doi: 10.1097/ICO.0000000000000206.
Results Reference
result
Links:
URL
http://www.pricevisiongroup.com
Description
Price Vision Group Website

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Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

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