Peter Quiros, MD, Associate Professor of Ophthalmology, Neuro-Ophthalmology, Doheny Eye Center at the University of California, Los Angeles, talks about a new trial drug to treat stroke of the eye.
Interview conducted by Ivanhoe Broadcast News in August 2017.
What the technical name for “Stroke of the Eye” and tell me what it is.
Dr. Quiros: The condition has a really long technical name and it’s called Non-Artertic Anterior Ischemic Optic Nneuropathy. What it really amounts to is there’s an interruption of blood flow for whatever reason to the optic nerve, it causes some of the fibers to swell, and the swollen fibers cut off a little bit of their neighbors blood supply, their neighbors swell and it’s just a cascade of events that usually leaves these people with about half the vision lost in one eye.
How long a process would that vision loss take?
Dr. Quiros: Patients often wake up with the problem and it will usually worsen over the first several days. So initially they may think it’s not anything serious. But then as it gets worse they usually will go to the doctor as a result, and that’s often when the diagnosis is made. Sometimes it’s delayed because it can smolder along for about a week or two.
What until now has been the standard of care for this?
Dr. Quiros: Back in the early 90’s there used to be a surgery that was performed for this. A study was then performed and it turned out that if you had the surgery you actually did worse than if we did absolutely nothing, which was observation. About a third of people actually showed improvement on their own without us having to intervene and do anything. It turns out though that in all subsequent studies that have tried many, many different treatments; nobody does better than just by plain observation. Those studies all showed less than thirty percent improvement rate in patients. So observation is the gold standard and since observation is risk free that’s what we offer. This new drug that is now a part of a placebo control double masked trial here at UCLA and other sites around the world, it works a little differently than a lot of the other medications that have been tried in the past. It blocks a cellular messenger that normally tells injured cells to die, it blocks that death signal. The hope is that if we can block the signal long enough, the cells will eventually recover from being swollen and instead of dying they’ll go back to recovering and functioning with this medication having been given. That’s why it has to be given right away. So in order for patients to be eligible for this study we need to see them within the first two weeks of their symptoms starting.
What have the results been so far?
Dr. Quiros: We don’t have results yet because the study has been ongoing for just a little under a year. The study is going to continue to recruit until about May of next year. At that point it will be closed to recruitment and then we will follow the patients out for one year and then analyze the data. Then we’ll actually know something about whether it’s working or not.
So is the hope then to reverse the loss of vision or to just stop it?
Dr. Quiros: A little bit of both actually. In the best of all possible worlds, we’d like to reverse some of the vision loss. We may not be able to reverse all of it but it would be nice if we can even get some improvement, because up to now we have no improvement. If we can only halt it at the level of when patients present, when they first come in, that wouldn’t be a bad thing either.
Talking to Steve Larson, he was misdiagnosed repeatedly so it doesn’t sound like something that every ophthalmologist would even be familiar to even diagnose to get them to you?
Dr. Quiros: Part of the problem is that optic nerve swelling can be seen in a lot of different conditions and so we often rely on the patients other associated symptoms. There are no other associated symptoms really with this disorder. Then we start to look at what’s their age and we look at the most common things that cause swelling for that age group. Unfortunately, especially in Steven’s case, he fell into an indeterminate age group where you could have any number of different conditions. This sometimes gets shoved to the end of people’s list and overlooked.
Who is eligible for this trial?
Dr. Quiros: Patients between the age of fifty and eighty are eligible for this trial. Those who basically have not had any treatment for this current episode. Because sometimes patients are given eye drops for this treatment or steroids as treatment and have had their symptoms come on within the last fourteen days.
And they just contact clinicaltrials.gov or live in this area?
Dr. Quiros: We have a referral number here at Eye Center UCLA and we also have a website as well that the sponsor of the study has put together for referrals for people nationwide.
Explain to us how the drug is delivered.
Dr. Quiros: This drug is delivered by an injection into the eye; it’s called an intravitreal injection. This is the same type of injection, the medication is different but the process for injecting is exactly the same as that for macular degeneration. Sometimes the same thing that is often used to treat certain types of diabetic retinopathy. The injection process is exactly the same so it’s a safe process.
One time or multiple?
Dr. Quiros: It depends on what part of the study you fall into. Because it’s double masked I don’t know whether the patient is getting the drug and the patient doesn’t know it either. And there’s actually five study groups so there’s a twenty percent chance you could get the placebo but there’s an eighty percent chance that you’ll fall in to one of the treatment arms. It’s a single dose low dose, single injection low dose, single injection high dose. Multiple injection low dose, multiple injection high dose.
So it’s still a Phase I trial then?
Dr. Quiros: A Phase II/III trial.
It is?
Dr. Quiros: Phase I is for safety and that trial was already done. UCLA was the participating center and that’s one of the reasons that the Phase II/III trial was done because it was noticed in that trial there was no really severe adverse reactions. And it was noticed that the people in the treatment group even though it was a small number did better than the placebo group in terms of their improvement rate.
What haven’t I asked you about the trial or the condition that you think is important to include in the story?
Dr. Quiros: The important thing is that people need to if they see a sudden change, if they experience a sudden change in their vision, especially if they’re age is greater than fifty and they have a history of high blood pressure, diabetes or sleep apnea that they should see their doctor right away so that they can get diagnosed and if necessary hopefully get treated.
Is this common or not that common?
Dr. Quiros: It happens about ten out of every hundred thousand people. It’s relatively uncommon.
How many people in the trial right now?
Dr. Quiros: There’s about two hundred and fifty people enrolled in the trial right now.
And how many people can you take?
Dr. Quiros: Well we can take as many as we can. The goal is to enroll approximately five hundred and eighty.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Janett Mendez
Sign up for a free weekly e-mail on Medical Breakthroughs called First to Know by clicking here.
