Ongoing Clinical Trials for Corneal Dystrophy
Currently, there are 4 clinical trials underway studying new treatments for corneal dystrophy, specifically focusing on Fuchs Endothelial Corneal Dystrophy. These trials are testing different medications administered as eye drops, including Ripasudil, STN1010904, and combinations of anti-inflammatory drugs, across several European countries including Denmark, France, Germany, Norway, and Spain.
Clinical trial locations
- Denmark
- France
- Germany
- Norway
- Spain
Study on Nepafenac and Dexamethasone for Reducing Inflammation and Swelling in Fuchs Dystrophy Patients After Corneal Transplant
This trial is being conducted in Norway and focuses on patients undergoing corneal endothelial transplantation, a type of surgery often needed for Fuchs’ dystrophy. The study compares two medication approaches after surgery: a combination of NEVANAC and Spersadex eye drops versus Spersadex alone.
Main inclusion criteria: Participants must be at least 18 years old and scheduled for DSAEK or DMEK surgery, which are specific types of corneal transplant procedures. They need to be able to cooperate during eye examinations and must be willing to give informed consent to participate in the study.
Main exclusion criteria: Interestingly, patients with Fuchs dystrophy are excluded from this trial. Additionally, those who fall outside the specified age range or are considered part of vulnerable populations cannot participate.
Focus and goals: The trial aims to determine which medication regimen is more effective in managing inflammation and preventing cystoid macular edema, a condition where fluid builds up in the retina after surgery. Researchers will monitor changes in the thickness of the macula and check for fluid-filled cysts in this area. The study also assesses eye pressure and visual clarity over time.
Investigational treatments: The study tests nepafenac, a non-steroidal anti-inflammatory drug (NSAID), in combination with dexamethasone, a steroid medication. Both are administered as eye drops. NSAIDs help reduce inflammation and pain, while steroids work by suppressing the immune system’s response to reduce swelling.
Study on the Effectiveness and Safety of STN1010904 Eye Drops for Patients with Fuchs Endothelial Corneal Dystrophy
This trial is taking place in France and is testing a new eye drop treatment called STN1010904, which contains sirolimus as its active ingredient. The study compares two different concentrations of these drops (0.03% and 0.1%) against a placebo.
Main inclusion criteria: Participants must be between 30 and 75 years old with a confirmed diagnosis of Fuchs Endothelial Corneal Dystrophy. Their vision must be at least 20/32 or better in the study eye, and they need to have a severity grade of 3 to 5 on the Modified Krachmer scale. Specific measurements of the cornea must show at least two out of three particular features, such as unevenly shaped corneal layers or displacement of the thinnest point of the cornea. Additionally, more than 50% of endothelial cells must be visible in imaging.
Main exclusion criteria: Patients without a confirmed diagnosis of FECD cannot participate. Those outside the specified age range or belonging to vulnerable populations are also excluded. Other specific health criteria must be met for safety and accuracy purposes.
Focus and goals: The study aims to assess how well the STN1010904 eye drops work in improving vision and corneal health over approximately 18 months. Participants will use the drops twice daily and attend regular check-ups that include vision tests, light sensitivity assessments, and detailed eye examinations using specialized equipment.
Investigational treatment: STN1010904 is an ophthalmic suspension containing sirolimus, which targets specific pathways in corneal cells to enhance their function and survival. This medication is designed to improve corneal health and clarity in patients with this progressive eye disease.
Study on the Safety and Effectiveness of Ripasudil Eye Drops for Patients with Fuchs Dystrophy After Cataract Surgery
This trial is being conducted in Denmark, Spain, and Germany, investigating Ripasudil (also known as K-321) eye drops for patients who undergo both cataract surgery and a procedure called descemetorhexis.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of FECD. They need to have confluent central guttae (small deposits on the cornea) that can be treated by descemetorhexis in an area of 5.5 mm diameter or less. Their vision must be 20/32 or worse, and they must have a cataract affecting their vision. After surgery, specific conditions must be met, including proper placement of the new lens and minimal complications during the procedure.
Main exclusion criteria: Patients with other eye diseases that could affect study results are excluded. Those who have had previous eye surgery that might interfere with the study, are currently using medications that could affect outcomes, or have severe medication allergies cannot participate. Pregnant or breastfeeding women, those who participated in another trial within the last 30 days, or individuals with medical conditions that could make participation unsafe are also excluded.
Focus and goals: The study examines how quickly vision improves within the first 12 weeks after surgery when using Ripasudil eye drops compared to a placebo. The treatment phase lasts 12 weeks, followed by a two-week dose reduction period and a 38-week follow-up phase to monitor long-term effects.
Investigational treatment: Ripasudil is administered as one drop in the study eye twice daily. It works by inhibiting a specific enzyme called Rho kinase, which helps reduce eye pressure and improve fluid drainage, potentially aiding the cornea’s healing process after surgery.
Study on the Safety and Effectiveness of Ripasudil Eye Drops for Patients with Fuchs Endothelial Corneal Dystrophy After Descemetorhexis
This trial is being conducted in Spain, Denmark, and Germany, testing Ripasudil eye drops specifically after the descemetorhexis procedure without concurrent cataract surgery.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed FECD diagnosis. They need to have confluent central guttae that can be removed by descemetorhexis. Their vision must either be 20/32 or worse, or if better than this, they must experience problems like glare, difficulty with stray light, or trouble seeing contrasts. After the procedure, it must be confirmed that the affected central corneal area measuring between 4.5 to 5.5 mm in diameter has been successfully removed.
Main exclusion criteria: Patients without FECD, those outside the specified age range, or individuals not fitting the defined clinical trial groups cannot participate. Those considered part of vulnerable populations are also excluded.
Focus and goals: Similar to the previous Ripasudil trial, this study assesses how quickly vision improves after using the eye drops compared to a placebo. The treatment period is 12 weeks, followed by a two-week dose reduction phase and a 38-week follow-up period. The primary measure is improvement in the ability to read letters on an eye chart.
Investigational treatment: Ripasudil (K-321) eye drops are applied directly to the eye. As a Rho kinase inhibitor, the medication helps reduce intraocular pressure and improve corneal health by affecting fluid dynamics within the eye.
Summary
All four ongoing clinical trials focus specifically on Fuchs Endothelial Corneal Dystrophy, a progressive condition affecting the cornea’s inner cell layer. Three of the trials test Ripasudil, a Rho kinase inhibitor delivered as eye drops, with two examining its use after descemetorhexis procedures and one after combined cataract surgery and descemetorhexis. The fourth trial investigates a different medication, STN1010904 containing sirolimus, while one trial focuses on comparing post-surgical anti-inflammatory regimens.
Denmark, Germany, and Spain show the highest concentration of trial activity, with multiple studies taking place in these countries. Norway and France each host one trial. The trials employ various approaches, from testing entirely new medications to comparing different combinations of existing anti-inflammatory drugs.
Most studies follow similar timeframes, with primary treatment periods of 12 weeks followed by extended follow-up phases lasting several months to monitor long-term safety and effectiveness. The trials share common goals of improving vision and corneal health while carefully monitoring for complications and side effects.
