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

• 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: Price Vision Group
• Information provided by (Responsible Party): Price Vision Group

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.

Condition or disease	Intervention/treatment	Phase
Fuchs' Dystrophy; Bullous Keratopathy	Drug: Prednisolone acetate; Drug: Fluorometholone	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 264 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty
• Study Start Date: October 2011
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of Eyes With Immunologic Graft Rejection Episodes [ Time Frame: Within 1 year ]

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Indiana

Price Vision Group

Indianapolis, Indiana, United States, 46260

Germany

University of Erlangen

Erlangen, Germany

Sponsors and Collaborators

Price Vision Group

Investigators

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

More Information

Additional Information:

Price Vision Group Website 

Publications of Results:

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.

• Responsible Party: Price Vision Group
• ClinicalTrials.gov Identifier: NCT01448213
• Other Study ID Numbers: 2011-0329
• First Posted: October 7, 2011
• Results First Posted: August 25, 2014
• Last Update Posted: September 3, 2014
• Last Verified: August 2014

Keywords provided by Price Vision Group:

DMEK; Rejection; Corticosteroid

Additional relevant MeSH terms:

Fuchs' Endothelial Dystrophy; Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Fluorometholone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents; Anti-Allergic Agents