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

August 22, 2014 updated by: Price Vision Group

Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany
        • University of Erlangen
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluorometholone 0.1% Solution
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.
Drug: Fluorometholone
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.
Active Comparator: Prednisolone acetate 1% Solution
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.
Drug: Prednisolone acetate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Eyes With Immunologic Graft Rejection Episodes
Time Frame: Within 1 year
Within 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Eyes With Intraocular Pressure (IOP) Elevation
Time Frame: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK
Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.
one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Price Vision Group

Investigators

  • Principal Investigator: Francis W Price, MD, Price Vision Group
  • Principal Investigator: Friedrich Kruse, MD, University of Erlangen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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