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

Bullous Keratopathy Clinical Trial

Official title:

Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448213
• Other study ID #: 2011-0329
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2011
• Last updated: August 22, 2014
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: August 2014
• Source: Price Vision Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bullous Keratopathy
• Fuchs' Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University of Erlangen	Erlangen
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Price Vision Group

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

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/IC — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eyes With Immunologic Graft Rejection Episodes		Within 1 year	Yes
Secondary	Number of Eyes With Intraocular Pressure (IOP) Elevation	Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.	one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK	Yes

External Links

•   Price Vision Group Website