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

Price Vision Group

Status and phase: Completed; Phase 2

Conditions: Bullous Keratopathy; Fuchs' Dystrophy

Treatments: Drug: Prednisolone acetate; Drug: Fluorometholone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448213

2011-0329

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

Fluorometholone 0.1% Solution

Active Comparator group

Description:

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.

Treatment:

Drug: Fluorometholone

Prednisolone acetate 1% Solution

Active Comparator group

Description:

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.

Treatment:

Drug: Prednisolone acetate