Nancy Holekamp, MD

 I have 1 last question for all 3 of you. I’ll start with David. What advice do you have for ophthalmologists and other health care professionals taking care of our patients with geographic atrophy [GA] or the earlier stages of age-related macular degeneration?

 The take-home message is that the times are changing. It’s no longer the mantra of, “We can’t do anything for dry age-related macular degeneration. We can’t do anything for geographic atrophy. We play no role in altering the course of that disease.” Hopefully, it’s a new day and a new time for our patients and our communities, so don’t hesitate to send us any patient you suspect may have signs of [age-related] macular degeneration. We’re happy to evaluate them and determine whether they qualify for the therapy and follow up with you about what we found.

 We’re fortunate to be retina specialists. I love what we do—we all love what we do—and this is a very exciting time. We finally have treatment for something we never had treatment for, and breakthroughs like this shouldn’t be taken for granted in medicine. For our colleagues out there, it’s important for them to know that we have options and that there are things we can do. As Dave said, get these patients in to see us so we can start stratifying them, because it’s going to come in a rush. We’re going from no treatment at all to 1 option and then potentially another option. It’s a very exciting time, and it’s a privilege to be here.

 I don’t want our colleagues to be underwhelmed by the 20% slowing of the growth rate of GA lesions, give or take some percentage points. This is the first treatment that alters the course of this neurodegenerative disease. I hope everyone will look at the FDA label once we get an approval and have a discussion with patients. Try to avoid a paternalistic approach to patient care, where we don’t think they’ll benefit. It’s hard for us to quantify and understand the disease burden caused by GA. We can’t hang our hats on visual acuity, and we may not be good communicators with our patients. Patients will select themselves. I encourage my colleagues to have a discussion with every patient who meets the label so that they understand the value proposition and to see if they want to proceed with this course of treatment.

 Well said. Before we conclude, I’d like to get brief final thoughts from each of you. David?

 This has been an excellent discussion. I learned a lot. It’s been a pleasure to hear all your voices. I’ve learned a lot listening to you guys. Thank you for having me.

 I agree 100%. This is where the magic happens. I love these discussions. I always learn a lot. Hopefully the audience learned a lot. Thank you for having us, Nora.

 I learned that in my injection clinics I’m going to have to monitor patients for safety, so thank you for that pearl.

 I couldn’t agree more. I’d like to thank you all for the very rich and informative discussion. I’d like to thank the audience. If you enjoyed the content, please subscribe to our e-newsletters to receive upcoming 

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Videos

Drs Eleonora M. Lad, David R. Lally, Jaynath R. Sridhar, and Nancy M. Holekamp share takeaways for health care professionals taking care of patients with geographic atrophy and earlier stages of age-related macular degeneration.

Advice to Physicians Treating Geographic Atrophy 

 Nora, you’re a world-class ocular imager. This is where I think AI could help that dynamic. Do you see a future where we will have software on our OCT [optical coherence tomography] machines that will make the diagnosis of GA [geographic atrophy], for not only us but also the primary eye care provider, so that it’s not a question of whether they’re right or wrong. I see AI as a very valuable tool on correct diagnosis prompting a correct and timely referral.

 Yes, in fact, they are. Thank you for asking this question. I’m excited because there are tools in development for this, especially for diagnosing geographic atrophy and predicting which patients will develop geographic atrophy. Some AI tools predict speed of progression for our patients. Hopefully it will be an easy readout, such as others that we’re used to: visual field readout, ECGs [electrocardiograms], and other areas of medicine that could be very useful to our referring colleagues.

Eleonora M. Lad, MD, PhD, shares how advances in ocular imaging, including AI tools, can improve diagnosis of geographic atrophy going forward.

Bringing Ocular Imaging to Primary Care Practices

 Can you talk to us about referral dynamics? How will we reach out to the community and be able to serve more patients with GA [geographic atrophy] and have them referred to you?

 It’s going to be very important for the retina community and the ophthalmology community to reach out to referring providers to educate them on a few things. No. 1, there’s still an old mantra among a lot of general ophthalmologists and optometrists that geographic atrophy is a slow disease. Why is that the mantra? Nancy, you can probably speak better to the mantra based on your experience, but my understanding is that before we had anti-VEGF therapies, neovascular AMD [age-related macular degeneration] was scary to everyone. That was the 1 where patients lost vision very fast. Because 1 was fast, the other had to be slow. We’ve learned with lots of natural history studies over the years that both can affect vision fast, not slow. Time matters for these patients, so we want them to know that this disease progresses fast, and that for the first time we have therapies that we can intervene and affect the rate for that patient’s vision loss. What do you think, Nancy?

 I agree. We have fast and slow just as we have wet and dry. It’s a very binary system, and it’s confusing to patients that you can have wet and dry [AMD] at the same time. It’s fun to think about how these terms that we use evolved over time. I’m very fortunate because I live in an area that has a very high medical and health literacy. I’m surrounded by high-quality optometrists and general ophthalmologists, and they all routinely do OCT [optical coherence tomography] scans in their offices. They’re very good at referring patients with wet AMD based on the OCT. They can see fluid and prompt a referral. I’m a more concerned about the referring doctors being able to accurately diagnose geographic atrophy; it could get missed. Although we may be moving toward OCT for clinical trials, it’s a little more sophisticated to identify the geographic atrophy and the OCT. Nora, maybe you agree with me?

 It’s not easy. The early lesions are difficult to pick up when they’re small, and they might be critically located where time is of essence. We have some educational needs. This is worth discussing. This will be a new drug, so we have a different patient population and degrees of speed of referral that are necessary. We’ll probably have to educate about the mechanism of action: we can’t administer the drug through intravitreal delivery, as we do for wet AMD, but we can manage adverse events. What educational tool, Jay, do we need for these programs to be implemented in clinical care?

 I love Nancy’s point about imaging. You’re right: OCT is ubiquitous. Even though it’s harder to diagnose GA with an OCT than it is with a fundus autofluorescence, maybe we need to start teaching referring doctors what to look for in OCT: transmission artifacts, involution of drusen, infrared imaging. That could be easy because there are smart, motivated people taking care of these patients and seeing them as frontline providers. They can get them to us when they need treatment. That’s a very low-hanging fruit. The natural history of GA is also great point, in terms of making sure people understand that.

The final thing is the understanding about area under the curve and quality of life. We’re all talking about how the 1-year data showed this lesion progression, but each patient is living that year. If you’re maintaining their vision or reducing the progression, it’s not just that their lesion progression was reduced by X percentage of the year. That whole year, their quality of life might have been better. Other fields have been good about talking about quality-of-life improvement over time. When you’re hearing about a 5-year survival rate in oncology, it’s about that extra time. That time is valuable. That conversation needs to be introduced here as well.

If you look at natural history data over 10 or 15 years, once we start using these drugs for a long period of time, hopefully there will still going to be a drop-off over time given what we know. It’s going to be, “What was that patient’s quality of life? What did they do during that year? Did they see their kids? Could they read? Could they function?” These were not captured in the trial data. This is important for people to understand because someone who looks at the data but doesn’t understand the nuances, might say, “Well, 20% isn’t a big deal. I’ll send that patient to see Dr Holekamp in 6 months.”

 I love your idea about a 5-year survival rate for the fovea because we can identify the foveal center, we know where the GA location is, and we can personalize that to every patient. Hopefully we can create a virtual reality of their projected 5-year foveal survival and what that would be lengthened to with treatment, even if the treatment slows the progression of disease and alters that slope by only 20% or 25%.

 One thing I’ll add is that we retina specialists need to make the referring doctor feel comfortable referring their patient to us. There are some marketing data that I learned about yesterday in which 1 of the biotechnology companies went to an optometrist’s practice and asked, “What’s the No. 1 reason you hesitate to refer a patient with suspected GA to your local retina specialist?” Not all patients with geographic atrophy are coming to us, and optometrists say the No. 1 reason is that they weren’t sure if it was the right diagnosis. They didn’t feel comfortable referring to a retina specialist in that situation if it was going to be the incorrect diagnosis. The attitude we should be taking is to tell optometrists to send us everything so we don’t miss patients in our community who may qualify for these therapies. Make them feel welcome to send us anything. It’s OK if it’s not geographic atrophy. We don’t want to miss anybody in the community who could have had access to these therapies.

 Do something all of us do: communicate back when that patient comes in. Give that feedback and say, “Thank you for sending that patient.” Even if it isn’t the right diagnosis or they’re not a candidate, I’m still glad that they got to see me. We can establish a plan that they follow.

Drs Eleonora M. Lad, David R. Lally, Jaynath R. Sridhar, and Nancy M. Holekamp discuss the need to improve the referral process through educating physicians about geographic atrophy.

Improving Referral for Geographic Atrophy 

 What are some of the considerations for introduction of these therapies in clinics, provided they become FDA approved? Leadership buy-in, access to therapy, training of the staff, coverage for these treatments, and a plan to ensure patient compliance and adherence? I’ll start with David.

 Yes, these factors matter greatly to our ability to employ these therapies. It’s not something we like to deal with as retina specialists. We want to use tools that we know have benefits for our patients, but our medical systems doesn’t always allow us to use tools as quickly or have accessibility to them. A lot of factors are going to be involved here: what’s the cost to the system? How are the products stored? How is the product made, what’s the manufacturing of the product like? Are insurances going to cover and payers going to pick up these therapies? They’ll also mandate that we treat a certain way with these therapies. Many factors are completely unknown right now that will affect the accessibility and usability of these products. What do you think, Jay?

 That’s a great point. Before we started this session, we discussed buzzwords. Nancy, you use the words 

. Those are buzzwords for the layperson. 

 is a buzzword. Unfortunately, we deal with real-world dynamics. People who are making decisions and involved in administration and insurance are laypeople who don’t always understand the terminology. Maybe 

 has. Just as we talked a lot about compliance for patients, we must apply that same education to our colleagues and leaders, and people must understand what we’re trying to achieve. Storage is going to be an issue. We don’t know what the drugstore is going to be like. We don’t know what the label is going to be like. We need to get buy-in from insurance carriers and from the people who are key players in our institutions. We need to get these patients in, so people who are referring doctors, optometrists, and ophthalmologists don’t keep saying come back in 6 months and don’t know that this an option. We’re going to have to do widespread education to get people on board.

 I couldn’t agree more. Once we have approval of a treatment for GA, there’s going to be a flood of very advanced disease coming in. We saw that when we had our first approvals for treating wet age-related macular degeneration [AMD]. That’s a good problem to have because we’re the specialists who can sift through to determine who will meet the label requirements and whom you can have a discussion with. At first, there will be a big flood, but we won’t reach everyone. We know that patients with GA are out there. They’re with their primary eye care providers. We must have a large educational campaign for general ophthalmologists and optometrists because we have a treatment. That’s very true.

As for adopting this into our clinic, 1 nice thing is that’s it’s an injection, and we know how to do that. Hopefully we can slot in any new medication into our office paradigm, but we may be overwhelmed. I’ve never had an injection clinic in my practice for wet AMD. I don’t know if you have, Nora or Dave. I might need 1. What are your thoughts?

 If this as successful as we want it to be, then that’s a good problem to have. We’re going to be overwhelmed. There simply aren’t enough injecting doctors in this country to take care of all the patients who are going to need treatment for geographic atrophy and the other diseases, which we already inject for that and are also increasing at an exponential rate. We’re going to have to do that on a micro basis. Working individually, we’re going to have to streamline our process for getting patients to injections and change the way we construct our clinics. We need to start thinking about this as a field. How do we approach this? We need to be proactive in terms of how we handle who does injections. Are injections done? Are we going to change the paradigms? Instead of a retina doctor doing your injections every month, is it going to be more like other subspecialties in medicine, like oncology or radiation oncology, where it’s a guided treatment plan but with someone else administering the treatment that you’re recommending? How do you foresee this happening?

 I agree. It’s going to be a challenge for our field that we haven’t seen before in terms of the burden of these patients already coming into our busy clinics. It’s important from a patient perspective—at least in the beginning until we see how this plays out over time—that the care is provided by a retina specialist. Why? It’s not because we need to change and make decisions based on what happens with the therapy in terms of the efficacy, at least in the beginning until we get more data. It’s more from a safety perspective. We retina doctors know how to look at an OCT [optical coherence tomography]. We know how to evaluate for CNV [choroidal neovascularization] and exudation. We can catch a little of the fluid that develops over a small PED [pigment epithelial detachment] much better than other eye care providers. We want to catch any safety events as early as possible because initiating therapy as early as possible to treat CNV is very important. In the beginning, until we have more experience, these injections should be performed by retina specialists in a retina care setting, or at least the treatment should be monitored carefully by the retina doctor.

 To your point about safety events, we’ve seen IOI [intraocular inflammation] and retinal vasculitis. These are things that, thankfully, most eye care providers don’t have to recognize or deal with daily. We know weird things can happen. That’s why you’re right. When you initiate new therapy, that’s going to be important. The other thing that’s probably important: do you think we’re going to see cost analysis data? We started this discussion by talking about the cost of geographic atrophy for society. Unfortunately, someone is making decisions as they should for anything. Is this something that insurance companies and American taxpayers should invest in? We’re going to find it is when we do cost analyses, in terms of the loss of function for patients, caregivers, depression, and mortality. There’s going to be a very clear benefit. We don’t know what the price will be for any of these drugs until we see a label, but it’s going to be important to show that, just like anti-VEGF, this is a therapy that not only save lives and is ethical but also probably saves the system money.

 Excellent point. The burden of care associated with these injections was a hot topic at this year’s American Academy of Ophthalmology Retina Subspecialty Day. It seemed to be a central theme throughout the day. In the United Kingdom, for example, nurses are performing most of these intravitreal injections. To your point, David, I agree that close monitoring of adverse events is important as the treatments are available to patients.

A panel of experts discuss what clinics need to consider when introducing new geographic atrophy treatments in their practice.

Nancy Holekamp, MD

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