Clinical trial NCT01448213: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fuchs' Dystrophy
Bullous Keratopathy
Keywords: DMEK
Rejection
Corticosteroid
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Eyes With Immunologic Graft Rejection Episodes
timeFrame: Within 1 year
Secondary outcomes:
measure: Number of Eyes With Intraocular Pressure (IOP) Elevation
timeFrame: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Erlangen
country: Germany
facility: University of Erlangen
Study officials:
affiliation: Price Vision Group
name: Francis W Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen, Germany
name: Friedrich Kruse, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.