Lucentis and Avastin Equally Effective for AMD
MAY 31, 2011
By Christine Vocke, Director of Education and Information, PXE International
On April 28, 2011, the New England Journal of Medicine published online the highly anticipated one-year results from a two-year clinical trial showing that Lucentis® and Avastin®, both manufactured by Genentech, were equally effective in preserving vision in people with wet age-related macular degeneration (AMD). Launched by the National Eye Institute in 2008, the study, called Comparison of AMD Treatment Trials (CATT) involves nearly 1,200 participants in 43 clinical centers in the United States. “In addition to the primary finding of equivalence between Lucentis and Avastin for visual acuity, CATT also demonstrates that PRN [pro re nata, or “as needed”] dosing is a viable treatment option for either of these drugs,” said Daniel F. Martin MD, study chair for CATT and chairman of the Cole Eye Institute at the Cleveland Clinic. “Substantial visual acuity gains may be accomplished with a lower treatment burden.” The study also reported that the safety of the two treatments was similar.
This is very good news for PXEers! Avastin and Lucentis have both been used to treat choroidal neovascularization and retinal bleeding due to pseudoxanthoma elasticum (PXE), and there have been several published studies on the positive results of Avastin use in small groups of patients with PXE. See Retinal Treatments, May 2010 for a report on two of these papers. A study published in 2011 by Scholl et al (1) on the long-term effectiveness of Avastin for CNV in pseudoxanthoma elasticum concludes that Avastin is effective in preserving function in advanced retinal disease of PXE, and improving function in early retinal disease in PXE. The 14 participants were monitored monthly for 28 months, and received injections depending on the disease activity. The mean age of the participants in this study was 55 years.
In contrast, the CATT study is monitoring 1,185 patients with active wet AMD, whose median age is over 80 years. CATT is a double blind trial where all participants receive a study drug, and there is no placebo group. Participants in CATT are randomly assigned to one of 4 treatment groups. Patients in each group either receive Avastin monthly, or as-needed (PRN), or receive Lucentis monthly or PRN. Both patients and physicians are blind to which drug is being used.
Participants who received monthly injections of Lucentis or Avastin experienced virtually the same improvement in their vision as those in receiving the drugs on an as-needed basis. In addition, those who received the drug only as-needed required four to five fewer injections per year.
All adverse events (worsening of any medical condition) are monitored and recorded in clinical trials, whether or not they are related to the drug being studied. Serious adverse events (primarily hospitalizations) occurred in 24 percent of the patients receiving Avastin, and 19 percent of patients receiving Lucentis. These adverse events were varied, and with the median age of participants over 80 years, a high rate of hospitalizations for various conditions would be expected. So far, CATT was unable to determine whether there is an association between the treatment and a particular adverse event.
The CATT study will continue to treat and follow patients for another year. Additional data will provide information on longer-term effects of Avastin and Lucentis on vision and safety.
Although the CATT trial follows participants with AMD, not pseudoxanthoma elasticum, all of this information will help PXEers make more informed choices in their treatments.
Read the National Eye Institute press release for more details
Finger RP, Charbel Issa P, Schmitz-Valckenberg S, Holz FG, Scholl HN. Long-term Effectiveness of Intravitreal Bevacizumab For Choroidal Neovascularization Secondary to Angioid Streaks in Pseudoxanthoma Elasticum. Retina. 2011 Jul-Aug;31(7):1268-78.