The following information was provided to me from the recent CATT Study training meeting held in Philadelphia.
(Please note the addended updates below.)
Patient enrollment for the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT Study) is set to begin before the end of the year, with enlistment beginning on December 1st.
The study will enroll about 1,200 patients with newly diagnosed wet AMD, randomly assigned to one of four treatment groups:
(Group1) Lucentis with four-week dosing, and after one year, re-randomization to Lucentis every four weeks or variable dosing as required based on diagnostic findings;
(Group 2) Avastin with four-week dosing, and after one year, re-randomization to Avastin every four weeks or variable dosing as required based on diagnostic findings;
(Group 3) Lucentis on a variable dosing schedule for 2 years; after initial treatment, with monthly evaluation and re-treatment based on signs of lesion activity; and
(Group 4) Avastin on a variable dosing schedule for 2 years; after initial treatment, with monthly evaluation and re-treatment based on signs of lesion activity.
The regimens are based upon the fact that Avastin is generally given on a variable basis and Lucentis has only been formally tested in a fixed regimen. The main objective will be changes in visual acuity, with secondary objectives including change in lesion size, fluid found in optical coherence tomography and cost, which the study chairman, Dr. Dan Martin of Emory University emphasized is not the sole purpose of the study.
The study will follow patients for two years and will take about four years to complete. One year follow-up data will be reported in late 2009. The study will be conducted in 47 centers in the US.
NEI/NIH is emphasizing that this is more than just a cost study, and that the primary goals are to better understand the safety and efficacy of intravitreal Avastin and to develop better dosing/re-treatment guidelines for both Avastin and Lucentis.
The Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) is a set of multicenter, randomized clinical trials of treatments for neovascular age-related macular degeneration (AMD), the leading cause of blindness in the United States. The Lucentis-Avastin comparison trial is supported by the National Eye Institute (NEI) of the National Institute of Health (NIH).
I expect to have a list of participating centers, hopefully with contact information, by the end of this week and will attempt to put it online. If it becomes available from the University of Pennsylvania website, I will link to that source.
Update:
I now have the CATT clinical site information on 46 of the 47 sites that are believed to be interested in participating in the clinical trial. I have been asked not to publish the names until the contracts with Upenn have been signed. I plan to honor that request.
However, anyone wishing to know the names of the clinics in their state that will be recruiting patients for the study can email me (iarons(at)erols.com – or the link at the side of this page) and I will be happy to cut and paste and supply you with the names of local clinics. Just mention the state that you are interested in.
As soon as Upenn gives me the OK, I will publish the information – or link to their site if they put it online.
I have also learned, as of 10/20/07, that the CATT Study will not be effected by the recent decision by Genentech to cut off the supply of Avastin to compounding pharmacies.
UPenn will act as the compounding pharmacy and will supply the doses of Avastin needed for the study to the 47 participating clinics.
The study will enroll about 1,200 patients with newly diagnosed wet AMD, randomly assigned to one of four treatment groups:
(Group1) Lucentis with four-week dosing, and after one year, re-randomization to Lucentis every four weeks or variable dosing as required based on diagnostic findings;
(Group 2) Avastin with four-week dosing, and after one year, re-randomization to Avastin every four weeks or variable dosing as required based on diagnostic findings;
(Group 3) Lucentis on a variable dosing schedule for 2 years; after initial treatment, with monthly evaluation and re-treatment based on signs of lesion activity; and
(Group 4) Avastin on a variable dosing schedule for 2 years; after initial treatment, with monthly evaluation and re-treatment based on signs of lesion activity.
The regimens are based upon the fact that Avastin is generally given on a variable basis and Lucentis has only been formally tested in a fixed regimen. The main objective will be changes in visual acuity, with secondary objectives including change in lesion size, fluid found in optical coherence tomography and cost, which the study chairman, Dr. Dan Martin of Emory University emphasized is not the sole purpose of the study.
The study will follow patients for two years and will take about four years to complete. One year follow-up data will be reported in late 2009. The study will be conducted in 47 centers in the US.
NEI/NIH is emphasizing that this is more than just a cost study, and that the primary goals are to better understand the safety and efficacy of intravitreal Avastin and to develop better dosing/re-treatment guidelines for both Avastin and Lucentis.
The Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) is a set of multicenter, randomized clinical trials of treatments for neovascular age-related macular degeneration (AMD), the leading cause of blindness in the United States. The Lucentis-Avastin comparison trial is supported by the National Eye Institute (NEI) of the National Institute of Health (NIH).
I expect to have a list of participating centers, hopefully with contact information, by the end of this week and will attempt to put it online. If it becomes available from the University of Pennsylvania website, I will link to that source.
Update:
I now have the CATT clinical site information on 46 of the 47 sites that are believed to be interested in participating in the clinical trial. I have been asked not to publish the names until the contracts with Upenn have been signed. I plan to honor that request.
However, anyone wishing to know the names of the clinics in their state that will be recruiting patients for the study can email me (iarons(at)erols.com – or the link at the side of this page) and I will be happy to cut and paste and supply you with the names of local clinics. Just mention the state that you are interested in.
As soon as Upenn gives me the OK, I will publish the information – or link to their site if they put it online.
I have also learned, as of 10/20/07, that the CATT Study will not be effected by the recent decision by Genentech to cut off the supply of Avastin to compounding pharmacies.
UPenn will act as the compounding pharmacy and will supply the doses of Avastin needed for the study to the 47 participating clinics.
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