Maureen Maguire April 1 2009

The Lucentis-Avastin Trial for Age-related Macular Degeneration – A Non-Inferiority Trial for which the Company Refuses to Pay for the New Drug Center for Clinical Trials Seminar Series Johns Hopkins University Maureen G. Maguire, PhD Department of Ophthalmology University of Pennsylvania

Disclosures I have no relevant commercial entity relationships or financial interests to disclose . I will discuss off-label use of Avastin

Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Public Health Significance of Age-Related Macular Degeneration (AMD) ,[object Object],[object Object],[object Object],[object Object],[object Object]

Early AMD ,[object Object],[object Object],[object Object],[object Object],Normal Early AMD

Impact of Early AMD on Vision ,[object Object],[object Object],[object Object],[object Object],[object Object]

Late AMD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Fluorescein Angiogram

Impact of Late AMD on Vision http://www.nei.nih.gov/photo/sims/index.asp

Age-Specific Prevalence of Late AMD in Whites Eye Diseases Prevalence Research Group. Arch Ophthalmol 2004; 122:564-572

Proportion of Adult Blindness by Race Eye Diseases Prevalence Research Group. Arch Ophthalmol 2004;122:477-485

Established Risk Factors for AMD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Prevention ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Treatment Efficacy for CNV at 1 Year- 2005 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Next Clinical Trial for CNV ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

History - Lucentis Arrives ,[object Object],[object Object],[object Object],[object Object],[object Object]

MARINA: 2 Doses of Lucentis vs Sham Rx Mean Change in Visual Acuity Over Time 21.4 letter difference* 20.3 letter difference* +7.2 +6.5 -10.4 2 4 6 8 10 12 14 16 18 20 22 24 Month -15 -10 -5 0 5 10 ETDRS letters -14.9 +5.4 +6.6 Note: Vertical bars are ± one standard error of the mean. * P <0.0001 (Rounded values) Sham (n=238) Ranibizumab 0.5 mg (n=240) Ranibizumab 0.3 mg (n=238)

Treatment Efficacy at One Year ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Planned Trial ,[object Object],[object Object],[object Object],[object Object]

History – Avastin Arrives ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Avastin Quickly Adopted by Many ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CATT History ,[object Object],[object Object],[object Object],[object Object],[object Object]

Centers for Medicare and Medicaid Services (CMS) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Centers for Medicare and Medicaid Services (CMS) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Centers for Medicare and Medicaid Services (CMS) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

2000 Clinton Clinical Trial Policy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CMS Options for CATT ,[object Object],[object Object],[object Object],[object Object],[object Object]

Comparative Effectiveness ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Demonstration Projects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Plan Proposed by CATT Group ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CMS “G” Code Plan ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CMS “G” Code Plan ,[object Object],[object Object],[object Object],[object Object]

CMS Capitated Plan ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CMS “Dr Fine Treats All” Plan ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Genentech Offers Drug ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Moving Forward ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CATT Resource Centers ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Primary Study Questions ,[object Object],[object Object]

Objective ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Major Eligibility Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Goal: Be as inclusive and simple as possible

Randomization Informed Consent Variable Avastin ® Variable Lucentis ® Fixed Avastin ® Fixed Lucentis ® Randomization

Randomized Treatment Assignment 0 Time 1 yr Lucentis Fixed Avastin Fixed Lucentis Variable Avastin Variable Fixed Vari-able Fixed Vari-able Lucentis Variable Avastin Variable Eligible Patients

CATT Study Drugs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Treatment Guidelines ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Masking ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CATT Treatment Masking Procedure Decides to treat Obtains drug Syringe filled and labeled Prepares the eye Injects Ophthalmologist Observes Clinic Coordinator

Maintaining Masking (CATT Training Mtg) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Maintaining Masking (CATT Training Mtg) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Would Our Central Masking Have Worked? ,[object Object],[object Object]

Outcome Measures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Follow-up ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Sample Size ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Is 5 Letters Close Enough? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Interpretation of CATT Not A Strict Non-Inferiority Trial http://bmc.ub.uni-potsdam.de/1468-6708-5-8/1468-6708-5-8-1.jpg Avastin - Lucentis Avastin Fixed Lucentis Fixed 5 5 Difference

Status April 2009 ,[object Object],[object Object],[object Object],[object Object],[object Object]

Medicare Act of 2008 ,[object Object],[object Object],[object Object]

Medicare and Clinical Trials 2009 ,[object Object],[object Object],[object Object],[object Object]

Summary ,[object Object],[object Object],[object Object],[object Object]

Maureen Maguire April 1 2009

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Maureen Maguire April 1 2009