Article Date: 7/1/2005

UPFRONT
Interesting Times for Retinal Specialists
Jason S. Slakter, M.D.

A Chinese philosopher once said, �May you live in interesting times.� Well, for the retinal community, these are certainly interesting times. Recently, it seems that not a week goes by where there is not an announcement of some new result from a clinical study on age-related macular degeneration (AMD), or an announcement from regulatory authorities regarding the status of approval of some new treatment, or an article appears regarding possible new diagnostic tests that may shed light on the underlying cause of retinal diseases. In just the past few weeks, we have seen early but impressive data on ranibizumab (Lucentis) from the Genentech Corporation. For the first time, a randomized controlled clinical trial for the treatment of exudative AMD has demonstrated a potential for improvement in vision rather than just control of visual loss. This study did focus only on patients with minimally classic or occult choroidal neovascularization, and all of the data has not been released, but certainly a great deal of excitement has circulated among our community. Just 1 week later, data from another trial of the same drug in combination with photodynamic therapy (PDT) with verteporfin (Visudyne) suggests improved visual outcomes in this combined modality as well. 

While exciting to speculate on potential ramifications of these trial results, we as retinal specialists have had to deal with a fallout of the popular press reporting of these findings. Many newspapers and television stations carried reports of �cure for AMD found� or �new drug reverses vision loss in AMD.� I am certain that there is not a single retinal specialist in the United States who has not been bombarded with questions regarding the use of Lucentis for reversing vision loss in patients that have end-stage disease, and having to deal with the disappointment that patients feel when they find out that this drug will in fact, not �cure� their disease.

Additional disappointment came in the last couple of weeks with the �approvable letter� issued for anecortave acetate (Retaane). It appears that we will have to wait at least some time before this drug becomes available for use in the AMD population. On a more positive note, the Food and Drug Administration did approve the Retisert (Bausch & Lomb) implant for the treatment of chronic uveitis, and this follows the recent approval of Vitrase (ISTA Pharmaceuticals) for management of vitreous hemorrhage. 

This rapidly changing environment, particularly for the treatment of AMD, was a highlight of the recent First Annual Retinal Physician Symposium held at the Atlantis resort in the Bahamas.  This meeting was a real success, providing an open forum for a free flowing discussion on the pros and cons of various diagnostic tests and treatments for retinal diseases. A summary of the meeting highlights appears in this issue.

The July/August Retinal Physician issue also features a review of the results of the transpupillary thermotherapy trials to help us better understand where things went wrong with the treatment as it is currently applied, and what the potential for this therapy is for the future.

This issue�s �face-off� column features a discussion of the pros and cons of the various treatments for retinal vascular occlusive disease including radial optic neurotomy, endovascular surgery, and sheathotomy. Another important article in this issue provides a summary of how to interpret clinical trials by �looking beyond the P value� in how a study is designed. With all of the clinical trials being presented, it is important for practicing physicians to understand how studies are designed, how the statistics are achieved and what their meaning is in the real world.

As always, we welcome your comments and questions as well as cases and articles for future issues. My best to all of you for an enjoyable summer.



Retinal Physician, Issue: July 2005