An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
This research is a 'Phase 3' study, which means it's one of the final stages of testing a new medicine before it might be made widely available. We're investigating an eye drop called cenegermin for people who have a long-lasting sore on the front of their eye, called a Persistent Corneal Epithelial Defect (PCED). This sore hasn't gotten better with usual treatments. The study aims to find out if cenegermin eye drops are better at helping these sores heal completely within four weeks, compared to an inactive eye drop (a 'vehicle'). We also want to understand if the new eye drop is safe. Participants won't know if they're receiving the active drug or the inactive one, and neither will their doctor. The study runs for a number of months, involving treatment and follow-up to see how people do over time.
At a glance
What is this study about?
Many people have problems with dry or irritated eyes, but some develop a more serious issue called a Persistent Corneal Epithelial Defect (PCED). This is like a sore or wound on the very front surface of your eye (the cornea) that just won't heal properly, even after trying common treatments. It can be quite uncomfortable and, if left untreated, could cause more serious eye problems.
This study is testing a new eye drop called cenegermin. Researchers believe this medicine might help the eye's natural healing process for these stubborn sores. To find out for sure, they compare it to an inactive eye drop, often called a 'vehicle' or placebo. This helps them understand if any improvements are genuinely due to the new medicine, or if they might have happened anyway or been due to other factors. Both the patients and the doctors won't know who is getting the active medicine and who is getting the inactive one, which makes the results more reliable.
The main goal of this particular study is to see if cenegermin eye drops can help these corneal sores heal completely within four weeks. They will also be carefully monitoring for any side effects to make sure the treatment is safe. Taking part in studies like this is really important because it helps develop new and better treatments for eye conditions that currently don't have many effective options.
Key takeaways
- This study is testing a new eye drop, cenegermin, for stubborn eye sores.
- It's a 'Phase 3' trial, meaning it's a key stage before potential wider use.
- The main aim is to see if cenegermin helps eye sores heal faster and if it's safe.
- Participants will not know if they receive the active drug or inactive 'dummy' drops.
- The study involves treatment periods followed by several months of check-ups.
- Eligibility depends on specific eye condition details and general health.
Who may be eligible?
To be able to join this study, you need to be an adult (18 years or older, or 19 in South Korea). You must have a sore on your eye that fits certain criteria: it needs to be at least 1.0 mm wide and have been present for at least two weeks without getting better, despite trying usual treatments like lubricating eye drops or special contact lenses.
You might still be able to join if you're taking other eye drops for conditions like glaucoma, as long as you've been on a steady dose for at least 30 days and don't expect it to change during the study. If you're already using antibiotic eye drops to prevent infection, that's generally okay too.
However, you won't be able to join if you have very poor vision in your other eye, or if you have an active eye infection (like bacterial or fungal) or active inflammation in the study eye. You also can't participate if the sore on your eye is linked to specific issues like significant thinning of the eye's surface, or severe eyelid problems that touch the sore. The study also excludes people with certain types of severe eye inflammation in recent months.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older?
- Do you have a persistent sore on the front of your eye that hasn't healed with usual treatments?
- Is your eye sore at least 1.0 mm wide?
- Have you had this eye sore for at least two weeks?
- Do you have good vision in your other eye?
- Do you have any active eye infections or severe eye inflammation?
What does participation involve?
If you decide to join this study, you will be part of it for about 40 weeks, which is roughly 9 to 10 months. For the first 8 weeks, you will receive either the study eye drops (cenegermin) or the inactive eye drops. After this, if needed, you might continue with the treatment for another 8 weeks.
Throughout these treatment periods, you'll have regular visits to the clinic so the doctors can check your eye's healing and monitor your health. After the treatment periods finish, you will then enter a follow-up period for about 24 weeks. During this time, you won't be using the study eye drops, but you will still have check-ups to see how your eye is doing long-term and to record any changes to your health. The exact number of visits will be explained by the study team, but they usually involve careful eye examinations and possibly other tests.
Potential risks and benefits
Locations (77)
- Azul Vision, INCVerified postcodeHuntington Beach, United States· Recruiting
- Harvard Eye AssociatesVerified postcodeLaguna Hills, United States· Recruiting
- Loma Linda University Adventist Health Sciences CenterVerified postcodeLoma Linda, United States· Not yet recruiting
- UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye DiseVerified postcodeLos Angeles, United States· Not yet recruiting
- California Eye Specialists Medical Group, Inc.Verified postcodeRedlands, United States· Recruiting
- East Coast Institute for Research - Florida Eye SpecialistsVerified postcodeJacksonville, United States· Recruiting
- Bascom Palmer Eye Institute, University of Miami School of MedicineVerified postcodeMiami, United States· Recruiting
- University of South FloridaVerified postcodeTampa, United States· Recruiting
- Massachusetts Eye and EarVerified postcodeBoston, United States· Recruiting
- Ophthalmic Consultants of BostonVerified postcodeBoston, United States· Recruiting
- University of Michigan Health - Kellogg Eye CenterVerified postcodeAnn Arbor, United States· Not yet recruiting
- Midwest Vision Research FoundationVerified postcodeChesterfield, United States· Recruiting
Common questions
What is a 'Phase 3' study?
Phase 3 is one of the final steps in testing a new medicine. It means the medicine has already shown some promise in earlier studies, and now researchers need to confirm if it works well and is safe in a larger group of people.
What is a 'Persistent Corneal Epithelial Defect'?
It's like a small sore or wound on the clear, front surface of your eye (the cornea) that doesn't heal properly or quickly enough, even after usual treatments.
Will I know if I'm getting the active drug or the inactive one?
No, this is a 'double-masked' study, meaning neither you nor your doctors will know whether you are receiving the active cenegermin eye drops or the inactive (dummy) eye drops. This helps make the study results fair and accurate.
How long will I be in the study?
The study involves an initial treatment period, possibly an extension, and then a follow-up period, adding up to about 40 weeks in total.
What if I experience side effects?
The study team will monitor you closely for any side effects. You should always tell them about any new or worsening symptoms you experience while in the study.
How to find out more
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
Always speak to your GP or specialist before deciding to take part in a study.
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