This article is more than 5 years old. Information may no longer be current.
AMD trials provide valuable data for physicians, patients
 Richard L. Lindstrom |
The National Eye Institute funded the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT), which is an extremely positive example of the power and influence of well-designed prospective clinical trials in which investigator bias is minimal to absent.
The bottom line: This is as believable as data gets. Ideally, we would have two more independent confirmatory studies, but this clinical trial is large and conducted by a diverse group of 44 study centers, making the data above reproach.
Now to interpret the data and apply it to everyday clinical practice. Here the controversy begins, as it is the interpretation of the data that leads to the critical patient management decisions we and our patients must make every day. While I freely admit I am well out of my area of expertise, I still see a significant number of patients with exudative AMD, and they want my opinion. This will be true for nearly all eye care providers.
So, what is my interpretation? First, CATT was an excellent and believable study. Second, it supports the use of either Lucentis (ranibizumab, Genentech) or Avastin (bevacizumab, Genentech). Third, I would want my patients to have either monthly injections or careful monthly follow-up. Finally, U.S. Food and Drug Administration approval and the Johns Hopkins data would make me lean toward Lucentis in patients in which excellent insurance coverage or wealth made money no object.
FDA approval is, in my opinion, very rigorous and difficult to obtain. Lucentis has it, and Avastin does not. In addition, FDA approval provides some level of protection for the treating physician. While rare, the potential of a patient suffering a cardiovascular or thromboembolic event in our litigious society may put the physician who uses Avastin at some risk. Of course, good informed consent should mitigate this issue, but it deserves thoughtful consideration. The cost of a treatment cannot be discounted, but for many patients, it is a non-issue. It is great news for thousands of patients that we have an inexpensive off-label alternative that appears safe and effective in this and other studies. Still, for the patient who says, “Doctor, money is no object, what do you recommend?” I will recommend Lucentis monthly if tolerated, and if not, compulsive monthly examinations with repeat injections as indicated.
We know Avastin will never achieve FDA approval as the costs are prohibitive and there is no incentive for the manufacturer to pursue it. We will hopefully have longer-term follow-up and mine more pearls of wisdom from CATT, but I suspect the next controversy will revolve around the safety and efficacy or VEGF inhibitors vs. VEGF traps.
In the meantime, Lucentis and Avastin represent a truly disruptive advance in our treatment for exudative AMD. To have two with a very promising third treatment on the way is nothing short of amazing. Once again, the magic of the innovation cycle and America’s biotechnology industry, clinicians and clinical scientists have produced a miracle to fulfill an unmet need and answer the prayers of thousands of patients worldwide. For me, the development of these drugs and the quality of the clinical trials performed to evaluate their comparative safety and efficacy make me proud to be an American and an ophthalmologist. Now we have to get to work and develop safer, less invasive and easier ways for patients and surgeons to deliver these and other intravitreal drugs. Stay tuned: These technologies are also on their way to us, thanks again to capitalism and the venture- and industry-funded innovation cycle.