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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01448213
Recruitment Status : Completed
First Posted : October 7, 2011
Results First Posted : August 25, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Price Vision Group

Tracking Information
First Submitted Date  ICMJE October 4, 2011
First Posted Date  ICMJE October 7, 2011
Results First Submitted Date  ICMJE August 4, 2014
Results First Posted Date  ICMJE August 25, 2014
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
Number of Eyes With Immunologic Graft Rejection Episodes [ Time Frame: Within 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
Incidence of immunologic graft rejection episodes [ Time Frame: Within 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
Incidence of intraocular pressure (IOP) elevation [ Time Frame: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
Official Title  ICMJE Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Fuchs' Dystrophy
  • Bullous Keratopathy
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Fluorometholone
  • 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.
    Intervention: Drug: Prednisolone acetate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2014)
264
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2011)
220
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01448213
Other Study ID Numbers  ICMJE 2011-0329
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Price Vision Group
Study Sponsor  ICMJE Price Vision Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francis W Price, MD Price Vision Group
Principal Investigator: Friedrich Kruse, MD University of Erlangen, Germany
PRS Account Price Vision Group
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP