Ongoing Clinical Trials for Corneal Graft Failure
Currently, there are 2 clinical trials investigating treatments related to corneal graft failure. These studies are exploring different approaches to prevent complications after corneal transplantation, including the use of immunosuppressive eye drops to reduce rejection risk and maintain the health of transplanted corneal tissue. The trials are taking place in the Netherlands and Germany.
Clinical trial locations
- Germany
- Netherlands
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This trial is focused on elderly patients who receive a kidney transplant and examines whether using a single medication approach works better than combining three different medications to prevent organ rejection while reducing infection risks.
Main inclusion criteria: To participate, you must be 60 years of age or older and be receiving either a deceased or living donor kidney transplant. You must not have donor-specific anti-HLA antibodies at the time of transplantation. Previous kidney transplant recipients can participate if they meet all other criteria. Both men and women are eligible, and you must be able to understand and sign an informed consent document.
Main exclusion criteria: You cannot participate if you are below 18 years or above 65 years of age, or if you have had previous organ transplants other than the current kidney transplant. Active or chronic infections, current pregnancy or breastfeeding, known allergies to immunosuppressive medications, and severe heart, liver, or lung disease will exclude you from the study. Other exclusions include active cancer or a history of cancer in the past 5 years, uncontrolled diabetes, mental conditions affecting your ability to follow study procedures, participation in other clinical trials within the past 30 days, history of substance abuse within the past 2 years, inability to provide informed consent, severe kidney dysfunction despite transplantation, history of organ rejection episodes in the past 6 months, or unstable medical conditions.
Focus and goal: The trial aims to determine whether using tacrolimus alone can reduce the risk of infections and improve quality of life compared to the standard treatment combining tacrolimus, mycophenolate mofetil, and prednisone. Participants will be followed for three years after transplant, during which researchers will monitor infection occurrence, kidney function, and overall well-being through regular medical tests.
Investigational drugs: The study compares tacrolimus as a single-drug therapy against the standard triple immunosuppressive therapy. Tacrolimus is an immunosuppressive medication that prevents organ rejection by weakening the immune system’s response to the transplanted kidney. The standard approach combines three medications to suppress the immune system and prevent rejection.
Study on Dexamethasone and Fluorometholone for Patients Undergoing Corneal Transplantation
This trial focuses on patients undergoing corneal transplantation, specifically a procedure called Descemet’s Membrane Endothelial Keratoplasty. The study evaluates two different eye drop medications to prevent complications after the transplant procedure.
Main inclusion criteria: You must be 21 years or older and registered as a candidate for Descemet’s Membrane Endothelial Keratoplasty corneal transplantation. Both men and women can participate in this trial.
Main exclusion criteria: You cannot participate if you have had a previous corneal transplant other than DMEK, have uncontrolled high eye pressure, severe eye infections or inflammation, or are currently using immunosuppressive drugs for other conditions. Patients with a history of severe allergic reactions to the study medications, pregnant or breastfeeding women, and patients with other serious health conditions that could interfere with study results are also excluded.
Focus and goal: The study aims to assess a treatment plan that reduces the risk of increased eye pressure and loss of corneal cells after the DMEK procedure. Participants will be randomly assigned to receive either dexamethasone or fluorometholone eye drops, or a placebo. The trial will monitor eye pressure and corneal health over a period of up to two years through regular check-ups. Researchers will also evaluate vision quality, patient satisfaction, and the overall survival of the corneal graft without rejection.
Investigational drugs: The trial tests two types of eye drops: dexamethasone (in the form of Dexamethason 1 mg/ml Teva eye drops) and fluorometholone (FML Liquifilm 0.1% sterile eye drops suspension). These are immunosuppressive medications applied directly to the eye that help prevent the body from rejecting the new cornea by reducing immune system activity. The goal is to find the right balance where the immune system is suppressed enough to prevent rejection without causing other health issues like increased eye pressure.
Summary
The two ongoing clinical trials represent different aspects of transplantation medicine, though only one directly addresses corneal transplantation. The corneal transplantation study is being conducted in both the Netherlands and Germany, while the kidney transplant study is limited to the Netherlands. Both trials share a common theme of investigating immunosuppressive therapy approaches, with the corneal study specifically examining topical eye drop medications including dexamethasone and fluorometholone. The trials demonstrate a focus on optimizing treatment protocols to minimize complications while maintaining adequate protection against graft rejection. The corneal transplantation trial is particularly relevant for patients undergoing the DMEK procedure and is expected to conclude by August 2028.
