Wednesday, January 23, 2008

CATT Study Update 5: First Official Listing of Clinical Trial Sites

Please see the update, posted on January 26, 2008, below.

The National Institute of Health officially listed the CATT Study on its web site today. The site contains information about the study, including its purpose; primary and secondary outcome measures; a description of the four treatment arms; eligibility; and a list of contacts and locations where the study will be undertaken.

However, the web site only lists 17 clinical trial sites, instead of the 46 or 47 that were supposed to participate. I have queried the principals to determine why the discrepancy.

In the meantime, here is the link to the web site:

Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

January 26, 2008

I have heard back from the sponsors of the CATT Study, who have provided me with updated information, current as of January 26, 2008.

The sites listed on the website were those with signed contracts with the University of Pennsylvania, the home of the CATT Coordinating Center, at the time of submission of information, January 3, 2008. UPenn currently has 24 centers under contract and the website will be updated shortly. It is my understanding that at least 45 clinical sites are expected to participate in the study.

I was also told that recruitment for the CATT Study will get underway on February 1st.

In addition, I was told that UPenn had received documentation that their first batch of re-packaged Avastin vials had passed all FDA-required release testing yesterday (January 25th) and the Center will begin shipping those vials on Monday. The Avastin was purchased through the UPenn Pharmacy and are using a cGMP facility that specializes in aseptic preparation of drugs. As previously noted, the CATT Study has not been affected by the changes in distribution proposed by Genentech.

I will keep providing updates as I receive them.


Post a Comment

<< Home