All right, so welcome to Real Talk. I'm very excited to have Alexandra Rucket-Skaya. Am I pronouncing that right, Alexandra? Perfect.
Perfect. Who is a associate professor at the Cleveland Clinic, Cole Ions, do very excited to have her? We're doing a mini journal club today, which is a new feature where we're starting out. There was a really fantastic paper published about six months ago, called the Clinical Use of Home OCT data to manage new vascular age-related macular degeneration.
It was published by the Journal of Victra Retinol Diseases, and very excited to have one of the co-authors there to walk us through that paper, what they found. The really exciting thing about this paper is that they used a new device that's from a company called Notal Vision, that does home OCT, and this is a really interesting area, because we know of all the problems that go along with managing these patients, the amount of injections they get. Alexandra, I'd love for you to walk us through the paper, and we can just jump right in. Thank you.
Well, thank you so much for having me. It's quite a pleasure to be here. I think you highlighted the need that we have within of the homology, in particular, within retina, and that's the burden of treatment. We're extremely lucky, right?
If you think we have these patients who have new vascular age-related macular degeneration, and we're able to improve and maintain vision for years. I have patients that I've been treating for over 10 years, and it's just amazing to look back and see that these patients can still see. The issue, though, is, of course, injections. I haven't met one patient who liked their injections.
The line that I usually get is, it's really lovely to see you, doctor, but I really don't like my injections. So, I think it's like some kind of a mini-fold treatment for those who haven't seen or done an injection. They're kind of like, what are you going to do to me? So there's that first conversation.
That's definitely right. The first conversation is always a little bit of a shocker to patients. Luckily, more and more patients have friends who will get treatments, and it's becoming a little bit more easy to talk about it. But the question is, can this new technology really help us personalize the injection treatments?
And because these days, we follow in general practice, we follow one or three approaches. You can treat monthly. You can treat as needed or PRN. Or most of us, I would say, probably vast majority do modify, treat, and extend.
You see patients, you see how they respond, and then you start extending based on that. Just to give a little background on some... So they don't... just correct me if I'm not asking.
They don't know... They're not going to get an injection. They go home for a couple of weeks. They may not know whether they're fluid that's forming in the back of their retina, just based off their vision or symptoms along.
Is that right? That's exactly right. And even more tricky is a patient that, let's say the patient comes in, they have fluid, you have the injection, you see them in four weeks, and they still have some fluid. So you don't know if the fluid went away and came back or if the fluid consistently stayed there since you treated them.
We have no way of assessing it, short of bringing that patient in a week or two weeks to do a no-city in the clinic. So the idea of homo-city is to provide personalized treatment based exactly on that behavior of the fluid. So there's the study that we did was kind of unique because the way was structured, these were patients who got homo-city imaging, but were treated as a standard of care. So the treatment in this cohort wasn't based on homo-city.
And then we took those segments of homo-city imaging and we asked 15 retina specialists to look at the segments and say, when would you treat this patient? So the retina specialists who were reviewing the segments had no idea when the patient was treated. Okay, so they just saw the images and they looked and they said, okay, I would treat this patient, I would not treat this patient. And if the answer is that I would treat the patient, the question was when.
And so we found the big take-home message was that we found that in about 40% of patients, the patients who were treated in clinical practice based on homo-city wouldn't need treatment. Okay, so that goes to the question of over-treatment. You know, potentially if you have a homo-city in 40% of patients, you wouldn't treat them when in reality they came back and got treated. The other interesting thing that patients who were chosen that they needed treatment in 60% of patients, those treatments would have happened earlier, about a week at least earlier.
So that goes to the conversation of under-treatment, right? So it's very interesting when we think about the role of homo-city, it's not only to say, oh, we're just going to monitor this patient and this patient potentially can go longer and there's definitely a cohort of patients that would do that. But there's some patients that we are bringing in, you know, not early enough and there's potential for under-treatment. And the big question is, you know, so we have this data and I think that's kind of the big message that we learn from this paper is then the next question is, what does it, how does it translate into any meaningful outcomes?
And so right now there's a big study by DRC RETNANELWORK, looking at the role of homo-city. And that study will actually, it's going to have more than 600 patients nationwide. And the study basically compares your standard of treatment extent, based on clinical imaging, clinical OCT in the clinic versus homo-city guided treatments. And looking at vision.
So we'll look at the number of injections, you know, how many injections the patients needed, over-treatment, under-treatment, but ultimately we'll also know what does it mean in terms of visual outcomes. So I really love this idea of having this device at home to essentially personalize treatment. Because as you're saying, not everyone is the same. Some people we need injections at a more frequent interval pattern and some will need it at a less frequent interval pattern, if at all.
And the idea is no two patients are the same. And this device, along with, and I'd love to learn a little bit about the AI implementation, because I know there is. But just take a little step back for our audience who may not be familiar or use OCTs routinely. You know, the OCT I haven't had in my clinic is really large.
There's a size of CT. So walk us through how the, just sort of take a step back on and just describe the device from no role. What it looks like, how it's used and compared to us for what you do in clinic. Yeah.
So definitely it's not your clinical CT. It's a portable device and actually it's very interesting because as part of the DRCR trial, if you travel, let's say the snow bird patients, they could actually ship the device to their other location. And I think it just highlights that the device is portable. It's, you know, it stands on the table and you put your face into it.
The other thing that was very important is the question that comes up, you know, our, and your Vascular MD patients are elderly, you know. Are these patients going to be able to utilize the device? And so there's been multiple studies and that's how we got the, of the approval, looking at the ability of the patients to use the device. And even patients who were as, with vision as poor as 2320, who were included in the studies, could use the device.
And I see it in, so I'm an investigator for DRCR study as well. And I see it because to qualify for the study, we have to show you that you can use the device. And we have a very varied patient population. You know, luckily a lot of our patients, even elderly, are very engaged and, you know, and kind of more, more utilized technology because of their children and grandchildren, you know, they know how to face time.
So it's, it becomes, it becomes easier. But I haven't had anybody who failed because failed screening because they couldn't use the device. You have a human factor design elements are so critical. And when I advise startups for working either in the hardware or software space because it still, it still matters that you have to really think about your core customer, which is, even if you're a need to be a platform, but your patients, right?
And how are they interacting with the technology, be it a device or software, making it easy for them and really understanding that, you know, in some of these, I'm sure you, the company has to think about low vision patients and make sure the text is readable. Yeah, so tell me a little bit. Walk us through. This is the AI and I, fair podcast.
Talk to us about the AI element. Because even if you're here, I definitely saw that there's some AI elements and, yeah, excited to sort of learn about that. Exactly. So, you know, one of the biggest concerns has always been so we have this device, the patients start using it and what's the burden on a physician?
They're using it every day. They're using it almost every day. Exactly. So you can imagine, you know, I, as a busy retina specialist, as most of us are, or a busy ophthalmologist in general, you don't have time to like go and look through so much data generated.
The more patients you have on it, the data is, it can be overwhelming. So that's where AI comes in and it basically looks at what's called hyper-reflective spaces, which ultimately represent in majority of cases intra-retinal and sub-retinal fluid. And so it identifies that those hyper-reflective spaces and quantifies them. So that's the biggest role of AI.
So in reality, if a patient is scanning, I don't want to get, you know, we all get emails, you know, it's just like every second there's an email, you want to get an email saying, hey, there's an alert, okay? And then you go in and you click and you see, and the interface is very nice and you click and see, okay, is this patient, does this patient need to be seen? And let's say you have a patient who has some cysts, right? And they persistently have like this cysts and you're not going to treat based on that.
Well, you can set up a threshold for a patient and AI is going to use your threshold so it's not going to, it's not going to alert constantly. So I think that interface between, so you have the, the machine, you have the patient who does the screening, you have a AI that allows the processing of images and allows for useful information, then be related to the physician and the team. And, you know, and you can, you can have different, we're still developing kind of the workflows for that, right? Because it's not utilized on large scale, how it's going to actually happen, who's going to get notifications, and how you're going to incorporate that into your clinic flow, clinic flow, that still remains to be established.
Yeah, I absolutely love that because, you know, AI is not a hammer that can be used anywhere. It should be designed to solve a problem in a sort of smart design workflow. And here, and this is what we see, not just with the home OCT devices, but other home devices that we can sort of talk about, but like, a visual field with the headset. And the amount of data that you're going to get as a physician, especially if someone's doing every day or sometimes even twice a day, or with the home IOP measuring, without a lot of companies are coming out with, the amount of data that comes in is so much, right?
And to have it in AI, someone says a triage assistant and as an agent to determine, well, what needs to be escalated to determine the next steps. And so I love the idea of having AI sort of help in that workflow management and solving that key problem of essentially too much data and helping it screen it forward the position in your case. So really, I think it's a really smart, smart integration. I think it puts a patient's at e.
I assume who would put the patients at e that, you know, you're actually being monitored, right? If you're not getting exactly on and not, you know, so are they contacting the, well, how does that follow contact work? Well, if you're a patient getting this scan, how does that, how does that happen? So there's actually, there's actually a way to be reminded, you know, so the, the images get captured.
So if somebody's not scanning, they can get a reminder to scan, which I think is nice too, you know, because we all know compliance is a big issue. And the new Vasculum D is a chronic disease, just like we were talking about glaucoma. So you need sometimes those reminders and that's built in as well to make sure that patients who are not scanning with the frequency that we're asking do scan. And, you know, a lot of times, for instance, in the study that we're conducting, you know, we want a scan, if there's some fluid, we want another scan to confirm that it's there and then, and then the patient gets contacted to, to be brought into clinic.
And I think it's, you know, there's two aspects of it from the academic standpoint, you know, I want to, you know, there's so much we can learn about the behavior of fluid and what happens. And we have so many options now in terms of agents to treat new Vasculum D. But also, there's a patient perspective and to your point, feeling that reassurance that you're being monitored. And I think patients are more and more comfortable with being monitored.
Like, you know, your smartwatch is monitoring your vitals basically. And so it's becoming more and more accepted. And I think patients like that. And then from purely clinical care standpoint, right?
And we all know that that some patients are under treated. And so that's another kind of way to minimize that and provide patients with appropriate treatment and hopefully actually impact their quality of life. Yeah, and ultimately, you know, improve their vision. I'm curious, and this may be a slight off topic, but in a world of sort of extended duration agents now, do you feel like this could be, I guess that could maybe be case that this could be more useful, but I could see how people would also think it's less useful.
So how do you think about that in a world of extended duration, but in teen therapy? How does that change? Yeah, I think it's a wonderful question because we are now looking at injections that potentially last several months. We're looking at such treatments as poor delivery system, right?
And poor delivery system in Vasculum D. It's six months or in some patients more. We've seen in face two clinical trial that some patients went over 12 months without needing treatment. And gene therapy is being investigated just like you mentioned.
So I think it definitely has a role because when we, you know, we discussed this in the redness space, what would you feel comfortable? How long would you feel comfortable not seeing the patient, right? And most people say maybe three months, you know, even though I don't, I'm not going to treat them, but I would like to see them. You know, I would like to make sure because we, some patients have various to it.
And maybe it has to do with eye dominance too. You know, I think it's multifactorial, but you, I have some patients and I tell them, you, my OCT, like you can, they consistently can tell me when they have fluid. And there's some, some folks that maybe it's their non-dominant eye or for whatever reason, you know, they have, they don't catch it in a way. They come in and only based on, they're like, oh, I'm totally the same.
And there's a lot of fluid. So, um, so it goes to that point of, uh, for those longer duration approaches, this might be a fantastic opportunity because then you, the physician, also reassured. Now, there is limitations, right? It's not, it's not meant, for instance, if patient has a hemorrhage, it's not going to catch that because it's not going to show as hyperflective space.
So, um, it has to be taken in consideration or other, you know, poor delivery system, you know, you need to make sure you look for any, any, any, surgical complications. So, uh, there's a lot of caveats, but I think it is, um, it is something that is very exciting. And I think we have to, and that's why I'm so, I'm thrilled about the DRCR study because I think we're going to learn what it means in terms of outcomes and also how to integrate it because if you think about it, the number of patients with new vascular MD in US and XUS, it's, it's just going to grow, grow exponentially as our population is aging. So, is it going to be for every patient, you know, is it going to be it for a subset of patients?
And that yet, uh, I think is not established and we're learning it as a community. Now, for our listens, for Dr. Schort interested in learning more and maybe even getting the device because it commercially available yet and can they go to a nodal of Visuals website and sort of learn more there. There's definitely a lot of information on the website and it is approved, but I don't believe it's commercially utilized right now.
Um, and, uh, I think it has to do with also payments and figuring out how you get reimbursed, although all of those aspects of it, but I will tell you the company is extremely approachable and very proactive. So, if somebody is interested in learning more, learning more about the DRCR study, there is a lot of information both on the RCR website and on the notile website. Wonderful. Thank you so much.
And we will, we will post a link to the full text of the paper at AI and ITERRA.com. I thank you so much, Dr. Rickinskaya, for your time today and looking forward to hearing more on this really cool device and cool developing space. Thank you so much.
Well, thank you so much and I thank you on behalf of all my co-authors as well.