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

NCT01448213 | Completed Phase 2 Results DMC

• 1 other identifier: 2011-0329
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 2

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.

Conditions

Fuchs' Dystrophy; Bullous Keratopathy

Keywords

DMEK; Rejection; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Number of Eyes With Immunologic Graft Rejection Episodes

  Within 1 year

Secondary Outcomes (1)

• Number of Eyes With Intraocular Pressure (IOP) Elevation

  one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

Study Arms (2)

Fluorometholone 0.1% Solution

ACTIVE COMPARATOR

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

Prednisolone acetate 1% Solution

ACTIVE COMPARATOR

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

Interventions

Prednisolone acetate DRUG

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.

Prednisolone acetate 1% Solution

Fluorometholone DRUG

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.

Fluorometholone 0.1% Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Price Vision Group: lead

Study Sites (2)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

University of Erlangen

Erlangen, Germany

Location

Related 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/ICO.0000000000000206.

  PMID: 25062336 RESULT

Related Links

• Price Vision Group Website

MeSH Terms

Conditions

Corneal dystrophy, Fuchs' endothelial, 1; Rejection, Psychology

Interventions

prednisolone acetate; Fluorometholone

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Marianne O. Price, PhD
• Organization: Cornea Research Foundation of America

mprice@cornea.org

317-814-2990

Study Officials

• Francis W Price, MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

• Friedrich Kruse, MD

  University of Erlangen, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 7, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 3, 2014
• Results First Posted: August 25, 2014

Record last verified: 2014-08

Locations

DE (1); US (1)