Clinical trials vs real-world data on wet AMD


Caroline Baumal, MD: Dr Rachitskaya, what are your treatment strategies, and how do you take some of the real-world studies that we know of and use that data to inform how you treat your patients?

Aleksandra Rachitskaya, MD: That’s a great question. Showing patients the images is useful because I think they also get invested. They get excited when they are doing well. They come to your clinic, they’ve already looked at their OCT [optical coherence tomography], and they say, “I’m doing so great,” or “I need a shot today.” Knowing that we do not have to have that discussion is great.

When we look at the studies, the patients have one set of outcomes. When we look at real-world studies or when we look at the extension studies, the outcomes are just not as good.

It is multifactorial; we must consider injection fatigue and compliance. A lot of these patients are elderly. We are also operating now in the world of COVID-19 [coronavirus disease 2019], and elderly patients have to rely on their caregivers and their families to bring them. Sometimes it feels like a burden to them. All those factors play into following the schedule that we set up.

There are 3 approaches that I think on average people use. It could be monthly injections, and a lot of studies utilize a monthly injection arm. You also have patients you see PRN [pro re nata, or as needed]. With the traditional PRN, the patient is seen on a monthly basis, but treated only if there is a presence of fluid in the eye or vision loss.

There is also treat and extend. In the cases of the classic treat and extend, you see the patient until they are dry, and then you start extending by 2 weeks, and you treat regardless. If they are still dry, you inject and then extend by a couple of weeks more. You can then cut back by a couple of weeks as well.

Some of the trials, especially the pivotal trials such as CATT, for instance, showed that on average, if you compare the monthly [injections] versus PRN, PRN overall does well. In the CATT trial, with PRN visits patients had about 2.4 letters worse than those seen monthly, but the outcomes are comparable.

On average, about 10% to 20% of patients require 3 injections or less a year, according to the CATT trial. If you commit a patient and treat them via monthly injection, you’re not going to catch those patients who might not need as many injections. We have all seen patients who, when we just do a couple of injections, improve and then they do not need as many injections.

In my practice, I use treatment extend because, with PRN, if you don’t treat them during their visit, if they have fluid in the 8 weeks between visits, they may experience discomfort or regress. We do not want them to have fluid, whenever possible. I try to keep them as dry as possible with a treat and extend regimen.

Caroline Baumal, MD: What about you, Dr Albini? What is your treatment strategy?

Thomas Albini, MD:I agree with Dr Rachitskaya and have similar experiences. This decision is very patient-specific and personalized to the individual, considering their family situation, and their ability to drive in. I agree that PRN is the optimal treatment paradigm, but that means that patients are coming in every 4 weeks, and patients often do not want or cannot do that. Some of them opt to do that and can do it without a problem, but most tend to do treatment extend. A little bit less than treatment extend is the reality of what they are doing. There can be more of an extension than there should be if they miss an appointment.

Now with COVID-19, it has been even more challenging. Seeing patients regularly has been difficult for the last 6 months, so it is really patient-specific what you do.

Caroline Baumal, MD: I usually use a combination of treat and extend, but I look at the patient factors. There are some patients who have a very small classic CNV [choroidal neovascularization] or type 2 CNV, and they really do not need many treatments. They are reliable patients who can do home monitoring or an Amsler grid. Eventually, we may have something like home OCT, so we can do PRN and not see patients monthly, but use OCT or other parameters.

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