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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Price Vision Group
• Treatments: Fluorometholone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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.