Researchers at the Hawaii Macula and Retina Institute conducted the clinical trial research that was necessary for the FDA to approve each and every industry changing therapeutic treatment for wet age-related macular degeneration:
- VIEW1: Eylea – Aflibercept FDA approved August 3, 2012
- MARINA: Lucentis – Ranibizumab FDA approved June 30, 2006
- VAM Trials: Photodynamic Therapy (Visudyne -Verteporfin) FDA approved April 2000
That meant subjects enrolled in our clinical trials had early access to these promising medications years before they were available on the market. It also meant our doctors had intimate, first-hand knowledge of the proper ways to administer, handle, and discuss these treatment options.
Until recent years, patients that developed wet age-related macular degeneration were often consulted on ways to adjust their daily lives to accommodate the inevitable loss of central vision. Reading and recognizing faces would become more difficult as our central vision is responsible for that sharp, detailed vision, which would continue to deteriorate as the damaged area affected by the macular degeneration would often continue to grow without intervention.
Focal laser, or laser photocoagulation along with Vertepofin Visudyne photodynamic therapies were early options, but none could prevent the eventual progression of vision loss – until Lucentis in 2006.
“Above the line” is often the phrase used to describe the graph that summarizes the breakthrough in wet-age related macular degeneration that was published via the MARINA results in the New England Journal of Medicine. With the center horizontal line representing vision if it remained stable over time, the blue line which drops below the lines showed the eventual decline of vision with conventional treatments prior to Lucentis. The red line, which ascends above the line of stable vision, was the revolutionary sign that the treatment of macular degeneration had taken a huge turn for the better! The pivotal MARINA trial study was conducted in Hawaii only by our researchers at HMRI.
Without the clinical development team at Genentech and the long timeline required by the FDA for approval of a novel drug like Lucentis, patients today would not enjoy the benefits of recovery of vision after the initial diagnosis of wet age-related macular degeneration. For patients that did not have access to one of the clinical trials that lead to the approval of Lucentis, treatment would not have been available until 2006. Patients at HMRI had access to Lucentis as early as 2003 – three years before FDA approval!
Where does that leave us today?
The best vision results on Lucentis therapy were obtained when injections were given monthly, and in most cases the need for re-treatment is inevitable when there is active macular degeneration in the eye. Until…. 2012. In 2012, Eylea was approved by the FDA with a slightly less burdensome treatment interval. The medication could be given once a month, but then decreased to a frequency of once every other month unless needed more often.
The clinical research trials for this breakthrough trial started at HMRI in 2007 – five years before the medication was available to the general public at the end of 2012.
Current research is now heading towards how to prevent macular degeneration and how to increasing the time between treatment intervals. It’s an exciting time for macular degeneration research and many options exist today for patients diagnosed with this debilitating condition.