Dr. Peter Kaiser is a Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine and a leading clinical researcher of retinal disorders. With contributions to 7 textbooks, 30 book chapters, and over 400 peer-reviewed manuscripts, he is a major voice in medical literature. He also brings his expertise to 20/20 Onsite as a member of our Industry and Scientific Advisory Board.
We spoke to Dr. Kaiser about how treatments of retinal disorders are evolving as well as the role of mobile vision care in the research driving these advancements. Keep reading to learn how hybrid clinical trials are helping improve these important treatments.
Give us some background on your experience and passions. What’s your why?
Dr. Kaiser: I am a practicing retina specialist. In the retina field, we have several of the diseases that cause the most blindness worldwide. Those diseases are age-related macular degeneration and diabetic retinopathy. I've spent the last 25 years working on better ways to treat both of these diseases.
We've come a long way. When I first started practicing, we just had laser treatment–which at best, prevented vision loss and at worst, caused a scotoma where the laser was placed. Nowadays, we have various injectable medications that usually improve vision and prevent this vision loss. Moreover, we're working on newer treatments that are even better than what we currently have.
It is an exciting time in terms of treatments to improve patient care, and most importantly, reduce blindness.
What are some innovations you're seeing in the ophthalmic research industry? Which are you participating in and which might you be skeptical about?
The way we treat most retinal diseases with injections is changing. Obviously, the injections work very, very well, but patients don’t like getting them and physicians don’t really like giving them.
That’s why we're working on different ways to address the problem with long-acting delivery devices, gene therapy, eye drops, and even pills that address these vision-threatening problems inside the eye.
The issue, of course, is that the eye is a protected place. As a result, it’s actually rather difficult to get some of our systemically delivered treatments to the eye–whether that be a pill or a subcutaneous injection.
Theoretically, the ideal delivery is an eye drop. However, because the retina is the back of the eye, it’s often difficult to get high enough levels when you use an eye drop. All these things are being researched because they'd be preferred to giving someone an injection in the eye.
For some diseases, we're starting to look at the use of gene therapy as treatment. Gene therapy is very exciting because gene therapy treatment would theoretically last for the patient's lifetime. We would be able to do one treatment and be done–essentially giving a patient a cure. We're very excited about that idea and the use of gene therapy in retinal diseases.
Are there any new treatments emerging more quickly than others?
To date, the studies of gene therapy have been extraordinarily promising. Although we have had some setbacks in the field, you learn and improve from each setback.
Another big area is the use of sustained-release polymers, where a drug is placed in the polymer to give a sustained delivery. That sustained delivery could be anywhere from six months to a year with just one injection.
The ideal situation is to put some of the drugs we currently have into these polymers, but that's not so easy because most of our current drugs are biologics. They're made in cell lines–in living organisms. Sometimes it’s difficult to put that type of drug into a polymer, but that's where technology has improved.
In the past, you could not get a biologic into a polymer, but we're excited because now I think we can start to see that. We are seeing some of these biologics going into polymer and having a sustained release, so it's a pretty exciting time.
You were going to speak about the patient journey from diagnosis to treatment at the Wet AMD conference. Can you give us a brief overview of some of your main talking points? Why is this topic important?
Particularly in dry macular degeneration, we're starting to have methods to prevent the progression of geographic atrophy. This is very exciting because this is probably the biggest unmet need. We have no treatment for dry macular degeneration. We have no way to prevent geographic atrophy from forming or progressing. It’s exciting that we may have not just one, but two possible treatments.
However, that begs the question of how to get patients into this treatment. What are the biomarkers on imaging that allow us to treat these patients? How do we follow some of these patients? How do we keep them coming back for treatment?
I really think this is a big problem because, unlike anti-VEGF treatments where the injection intervals are getting much longer, these newer treatments for geographic atrophy are back to one injection every month or maybe every other month.
For patients in rural areas or far from a retina specialist, it’s a big challenge to get those patients treated appropriately. It's something that we need to work on very closely with pharmaceutical partners, insurance companies, and even the government to ensure we treat these patients who may have difficulty getting care.
How do you see mobile vision care playing a role in improving the patient experience in clinical research? What made you want to work with 20/20 Onsite?
20/20 Onsite has several areas that can be of benefit to patients in the retina specialty. First and foremost, the patient pool to get into clinical trials is limited. Many patients are unable to come for their visits.
Through 20/20 Onsite, we have a van with all the imaging devices we need for the clinical study and an investigator who goes to the patients to deliver both imaging and treatment. This can eliminate a lot of the travel issues.
For instance, many patients are in assisted living. They may not have family members who can do the visits. It’s a game-changer to be able to go to them instead of making them come to us. During the pandemic, this was particularly true because many patients were scared to visit their doctor's office. The van is contained and can be sterilized in between patients. That really helps keep patients in clinical studies and ensures they get the treatment we want.
Plus, as I mentioned before, many of our patients are in rural communities or in a nursing home in a major city and don't have somebody to bring them to the doctor. That's where it helps to have a mobile ophthalmologist office that can go to these sites. At an assisted living facility, several patients can be treated on a given day.
Then a month or two later, the van comes back and all those patients can be treated and evaluated again. The idea of only getting your care in an ophthalmologist's office can really change in the future with companies like 20/20 Onsite.
What would you say to other retina specialists who might be reluctant to use a mobile clinic like 20/20 Onsite?
I think the biggest resistance is competition. Retina specialists want to keep their patients. They don't want another physician delivering care to their patients.
However, if we get some of these new treatments for geographic atrophy, our injection volume is going to skyrocket. We simply cannot perform that many injections, so offloading some of the intervening injections to a service like 20/20 Onsite makes sense.
We're not losing our patients. We're letting that patient get treated in between, and maybe we'll see them every six months or twelve months to make sure that the plan is going as expected and to ensure we have a plan going forward. Partnering with 20/20 Onsite is not giving up a patient. That idea is difficult for many retina specialists to understand. You're not giving the patient up, you’re sharing the care.
What are some of the other benefits of using onsite care?
One major challenge we’re facing is that we can’t get to all the patients we need to, and this is going to become a bigger problem in the future. We already know we don't have enough retina specialists to treat all the patients entering the age groups for many of these diseases, so we need help.
Although we may not set up an office in some of these rural areas, we could have the 20/20 Onsite van go to the patients.
This is a great opportunity to decrease vision loss. To most of us physicians, that's really the holy grail. We do this to help patients. If we can't help them directly, we can get them help another way. That really is why we do this.
There are many situations where an ophthalmologist is necessary, but it might not be cost-effective to have one onsite. What do you think about that challenge as we work to increase patient access?
Pharmaceutical companies and people who design clinical trials need to take this into account when designing studies. Not every visit requires an ophthalmologist. A lot of this can be done with imaging or with a technician.
For instance, in a dry AMD study, you don't need to see the patient as frequently. You need the opthalmologist to do an injection, but there are many visits where you just do a follow-up. That could include an imaging exam, a visual function questionnaire, checking their pressure, or taking a photograph to look for adverse effects.
These are all things that could be done with the 20/20 Onsite van. You just need to think outside the box instead of saying every visit must be at the clinical site, which is very expensive for pharmaceutical companies and very time-consuming. Some of those visits can be offloaded, and injections or other procedures, where an ophthalmologist needs to be present, can be done at the site.
It just requires a little different thinking, which we started to do during the pandemic when we cut back on visits for clinical studies. We stepped back and said what is the absolute minimum that we can do? With a van, we keep our visits to a minimum, but we send the van out to safely see patients.
Are there any experts leading the charge in designing hybrid clinical studies?
There are several pharmaceutical companies that have taken this idea and actually run with it. A big question is: what can be done and is covered by IRB? If you use a central IRB, it's actually not that difficult to get the 20/20 Onsite van covered because the technicians are certified like any other technician in a clinical trial.
It's a little harder for studies where they want to send the actual investigator out. That's one way to do it. The other way to do it is to use the van to visit an assisted living facility to screen for patients.
The patients who meet the screening criteria can go to the clinical trial sites, and this really increases the yield. To a pharmaceutical company, getting patients is the goal. They want that, and they're willing to invest whatever it takes to get more of that as opposed to patients at a clinical site where many more visits are required just to find one or two patients that meet the criteria.
In this case, you're saving everybody time. It’s very difficult to find patients for some studies. Anything we can do to cast a wider net is beneficial because physicians and clinical sites often have referral patterns that can be hard to expand.
Is there a topic you look forward to speaking about at our next meeting?
I really want to see more and more studies use this idea to go out into rural communities. For instance, one of our best clinical sites is in North Dakota where there is only one retina site.
If we can bring the patients to them efficiently with the 20/20 Onsite Mobile Vision Clinic, we can improve our ability to treat patients in that community. I look forward to figuring out how we can get more companies involved with 20/20 Onsite.