Saturday, November 07, 2009

Avastin/Lucentis Update 34: More on the Comparative Studies

In my constant search for new information about AMD treatments, I happened across a blog devoted to all things retina: The Retina Blog. In one posting, following the recent AAO Meeting, author David Khorram reported on Dan Martins talk during the Retina SubSpecialty Day Meetings. Apparently, the Academy sent out an email on its Academy Live network describing Dan’s talk in more detail than I had received.

Anyway, The Retina Blog had the up-to-date details on both the CATT Study and most of the other head-to-head studies – although, news about the Spanish study appears to be missing.

Here, thanks to David Khorram, is the latest information on the comparative studies.

Head-to-head Lucentis vs. Avastin Trials

The Retina Blog – David Khorram, MD

This bit of news just came in from the annual meeting of the American Academy of Ophthalmology, which is being held right now in San Francisco. There is a lot happening in terms of these two drugs. The results will be important, both clinically and economically. Lucentis costs $2,000 per dose. Avastin costs less than 10% per dose. Both drugs are made by Genentech — that’s a whole different story. Here is a list of the current clinical trials as described in the article from the “Academy Live” email of Friday October, 23, 2009, a service of the American Academy of Ophthalmology.

Bevacizumab vs. ranibizumab: Initial results expected in 2011

Bevacizumab (Avastin) and ranibizumab (Lucentis) are competing in a hefty schedule of six head-to-head randomized clinical trials directly comparing their use in AMD patients, said Daniel F. Martin, MD. This year, researchers hope to complete enrollment in the studies, which compare varying doses and treatment schedules of the drugs. Initial study results are expected to be available in early 2011, according to Dr. Martin.

Here’s the status of each of the studies:

* The NEI-sponsored CATT (Comparison of AMD Treatments Trial) study began enrolling an estimated 1,200 wet AMD patients at 44 sites in the United States in February 2008. The four-arm study comparing bevacizumab and ranibizumab on fixed and variable schedules is proceeding well, according to Dr. Martin, with one-year results targeted for 2011.

[Editors Note: According to Dr. Martin, enrollment is expected to be completed by the end of November, at which time enrollment will be closed. For more on the CATT Study, see my CATT Study Update 10.]

* In April 2008, researchers in the United Kingdom began enrolling an anticipated 600 patients at 17 sites in the IVAN (Inhibit VEGF in Age-related choroidal Neovascularization) study. This four-armed study compares monthly bevacizumab 1.25 mg and ranibizumab 0.5 mg injections given over two years with three monthly injections followed by PRN dosing.

* The four-site German VIBERA study started enrolling 360 AMD patients in 2008 to receive three monthly bevacizumab 2.0 mg or ranibizumab 0.5 mg injections and additional injections as needed.

* The Austrian MANTA study began assigning an anticipated 320 AMD patients in June 2008 to three monthly bevacizumab or ranibizumab injections, with additional treatment as needed.

* Researchers in Norway began enrolling an anticipated 450 patients in the 12-site LUCAS study in March. Subjects receive bevacizumab 1.25 mg or ranibizumab 0.5 mg monthly as needed until dry, with intervals between doses decreasing over time.

* French investigators opened enrollment this fall in the 600-patient, 20-site GEFAL study. Subjects are randomized to receive three initial monthly injections of one of the two drugs.

[See my Update 25 for more on the French study.]

David Khorram, MD is the co-founder of Marianas Eye Institute, and the medical director of the Center for Advanced Diabetic Eye Care. A US-trained Board Certified ophthalmologist, he is listed in "Guide to America's Top Ophthalmologists."


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