Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK) - Full Text View

Purpose

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	Intervention	Phase
Cornea Transplant Recipients	Drug: Prednisolone acetate Drug: Fluorometholone	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Steroids

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Fluorometholone Prednisolone sodium succinate Methylprednisolone sodium succinate Fluorometholone acetate

U.S. FDA Resources

Further study details as provided by Price Vision Group:

Primary Outcome Measures:

Incidence of immunologic graft rejection episodes [ Time Frame: Within 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	October 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448213

Locations

United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260

Sponsors and Collaborators

Price Vision Group

Investigators

Principal Investigator:

Francis W Price, MD

Price Vision Group

More Information

Additional Information:

Price Vision Group Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Price Vision Group
ClinicalTrials.gov Identifier:	NCT01448213 History of Changes
Other Study ID Numbers:	2011-0329
Study First Received:	October 4, 2011
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Price Vision Group:

DMEK
Rejection
Corticosteroid

Additional relevant MeSH terms:

Methylprednisolone acetate
Prednisolone acetate
Fluorometholone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013