Thursday, September 27, 2007

CATT Study Update 3: Avastin vs. Lucentis – To Get Underway by Year’s End!

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.



10 Comments:

At 9:31 AM, Anonymous Anonymous said...

Mr. Arons -

Nice article. It is good that you are attempting to get this information out to patients that need it...i find many of our macular degeneration patients are quite internet-savvy and often ask intelligent questions about their condition and the various treatment modalities for ARMD, because of what they have learned by researching online. However, many macular degeneration patients are still unaware that clinical trials are a great way to contribute valuable data for emerging treatments, especially in cases were conventional treatment has failed to stop the progression of their disease.

Sincerely,

Christina Consolo, CRA COT
Member, OPS Board of Directors
Clinical Research Ophthalmic Photographer
Vision Research Foundation
c/o Associated Retinal Consultants
Royal Oak, MI
christinax4@yahoo.com

 
At 11:51 AM, Anonymous Anonymous said...

I would love to see the list of clinicals that are performing CATT studies.

 
At 1:11 PM, Blogger Irv Arons said...

anonymous -- if you send me an email, I will gladly provide you with what clinics are participating in your state.

Irv Arons

 
At 8:10 PM, Blogger Jill said...

I am a patient diagnosed with wet macular degeneration. I received my first Avastim injection in January and am due to receive the second one tomorrow. I am distressed to hear that the drug may become unavailable to my retinologist. What are people in my situation supposed to do?

 
At 8:14 PM, Blogger Jill said...

I was diagnosed with wet macular degeneration in September 2007 and began treatment with Avastin in January, 2008. I will receive my second injedtion tomorrow. Your information distresses me in that my retinologist has not mentioned any reason to believe he will not be able to get a continuous supply of the medication. Should I be concerned or consider contacting one of the locations participating in the clinical trial? Please send me a list of those who might be accessible in the Asheville, NC region.

 
At 12:45 AM, Blogger Irv Arons said...

Jill,

If you read the update, you'll find that the supply of Avastin has not been cut off. Gennentech and the AAO and ASRS have reached an accommadation so that Avastin will continue to be supplied to retinologists, who can then have it "cut" into the appropriate dosage for their patients.

Also, since you have already begun treatment, I don't believe you are eligible for the CATT Study which is seeking first time patients.

Irv Arons

 
At 12:32 PM, Anonymous Anonymous said...

Is this study open to people with CRVO? I had an injection two days ago and was diagnosed with CRVO less than 2 weeks ago.

 
At 11:58 AM, Blogger Lois said...

Can you provide me with the name of the study which found that 1.2% of subjects who took 0.5 mg of Lucentis every 4 weeks developed stroke as opposed to only 0.3% of subjects who had an injection of 0.3 mg?

 
At 11:14 AM, Blogger Irv Arons said...

As I recall the program requirements, you probably would not be a candidate. However, the best way to find out would be to contact one of the participating centers and asking them directly.

This site contains the list of participating centers and a contact list:

http://www.nei.nih.gov/catt/studycenters.asp

Irv Arons

 
At 11:18 AM, Blogger Irv Arons said...

Lois, I'm sorry, but I cannot.

Irv Arons

 

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