A Lesson in Evolution

The introduction of a viable therapy for exudative AMD challenged us all.

BY JASON S. SLAKTER, MD

Sea change… paradigm shift… game-changer… revolutionary… breakthrough. In the retina world, only one therapy in the last 4 years has consistently been described in these terms: ranibizumab (Lucentis, Genentech), which was approved in 2006 to treat exudative age-related macular degeneration and now is also indicated for macular edema following retinal vein occlusion.

Lucentis literally revolutionized the management of patients with exudative macular degeneration. Previously, therapeutic options were fairly limited. We were able to maintain vision in some patients or slow their vision loss, but with Lucentis, we could offer patients a chance for better vision. It really was a sea change in the way we managed our patients.

Even those of us involved in clinical trials of ranibizumab did not fully appreciate what the impact of the drug would be on our patients' lives and our day-to-day practices until all the data were analyzed and the drug was FDA-approved and available to all. Along with the ability to improve a patient's quality of vision, Lucentis therapy also challenged us in managing our patients from a practice point of view, as well as from a patient's financial and personal point of view. The Lucentis introduction changed the game, so to speak, in all respects, and I think it fundamentally changed the way we practice on a daily basis.

The first challenge was one of conceptual management of our patients. Until the introduction of Lucentis, we were trying to keep patients with macular degeneration from getting worse. So we would monitor them. We would offer them treatment when things looked like they were going bad or if they were getting active. The idea of giving patients a therapy when they were doing well was new to us. All previous treatments for macular degeneration carried potential for additional damage, so we were always weighing the risks and dangers of the therapy versus the relative benefits to the patient, which, at that point, was slowing vision loss.

All of a sudden, we were faced with a new treatment paradigm. We had to grasp the concept that ongoing, repeat therapy — even when a patient had good vision — was, in fact, in their best interest over the long term to maintain or further improve their vision. That required a shift in our management approach for macular degeneration to one more typically seen with other conditions, such as diabetic retinopathy. In diabetes, we know the high-risk characteristics for future vision loss, and we treat with the laser even when the visual acuity is good to forestall the development of vision-threatening edema. With macular degeneration, however, we had never dealt with that before and this necessitated a whole new way of thinking.

Our second challenge was to change our patients' practices. These patients were accustomed to being seen maybe every 3 or 4 months if they had symptoms. But we were asking them to come in for monthly assessments and possible treatment, and that treatment was via intravitreal injection. If you attended a professional meeting 10 years ago and heard that you would be bringing patients back every 4 or 5 weeks and giving them an injection in the eye, you would not have believed it. Today, it is the accepted routine in our practices.

Even if you did not increase the number of patients you saw, the number of visits would potentially double or triple. This immediately presented a dynamic challenge: How do you manage the increased volume? What's more, this new treatment opened the doors for more patients to be treated. Not only had you introduced a new procedure to your daily routine, you had also radically changed the volume of the practice.

Nearly simultaneous with the introduction of Lucentis was the widespread introduction of OCT imaging, presenting a new diagnostic modality to add to the practice. And finally, we had to consider the economics of managing an expensive drug that is essentially purchased by the physician and reimbursed by third parties. Retina specialists are resourceful, and as the challenges became apparent, we set about to address them. In this supplement, we share some of the solutions achieved in various practices. Some are as simple as carrying a calendar in your pocket, while others are a bit more complex, such as a bar-code solution that is still in development.

The bottom line is that we have been given a drug that saves vision. It has challenged us, and it has required us to be creative and do things differently. Our practices are fundamentally different than they were 5 years ago. Life changes, and we evolve. I encourage all of us to look at the positives and find ways to adapt. RP