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Ranibizumab and bevacizumab for neovascular armd * The CATT research group*

Ranibizumab and bevacizumab for neovascular armd * The CATT research group*. Juan G. Santiago, MD Valley Retina Institute, P.A. May 6, 2011. Background. In 2005, clinical trials have established the efficacy of ranibizumab ( Lucentis ) for the treatment of neovascular AMD.

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Ranibizumab and bevacizumab for neovascular armd * The CATT research group*

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  1. Ranibizumab and bevacizumab for neovasculararmd*The CATT research group* Juan G. Santiago, MD Valley Retina Institute, P.A. May 6, 2011

  2. Background • In 2005, clinical trials have established the efficacy of ranibizumab (Lucentis) for the treatment of neovascular AMD. • Ophthalmologists began treating neovascular AMD with off-label bevacizumab (Avastin). • Bevacizumab is the most commonly used drug in the US for neovascular AMD, despite the absence of large scale clinical trial data supporting its use

  3. Background • As needed regimen has been adopted widely for Lucentis, instead of the monthly regimen used in the pivotal trials. • Comparison of Age Related Macular Degeneration Treatment Trials (CATT) • Assess the relative efficacy and safety of Lucentis and Avastin • Determine whether as needed treatment compromise visual acuity, as compared to monthly treatment.

  4. Methods • 1185 patients at 43 clinical centers in the US • Eligibility criteria • 50 years or more • Untreated active CNV due to AMD • Leakage on FA • Fluid on OCT • Within or below retina • Below RPE • Hemorrhage under fovea • VA between 20/25 and 20/320

  5. Study Groups

  6. As-Needed Groups • Treatment if signs of active neovascularization • Fluid on OCT • New or persistent hemorrhage • Decreased VA compared to previous exam • Dye leakage or increased lesion size on FA

  7. Outcomes • Primary • Mean change in VA between baseline and 1 year • Secondary • Patients with a VA change of ≥ 15 letters • Number of injections • Change in fluid and foveal thickness on OCT • Change in lesion size on FA • Incidence of ocular and systemic adverse events • Annual drug cost

  8. BASELINE CHARACTERISTICS

  9. Age

  10. Mean Age

  11. Sex

  12. Race

  13. Serious systemic event

  14. Blood Pressure

  15. Snellen equivalent

  16. Mean visual acuity score

  17. Retinal thickness

  18. Foveal center involvement

  19. Findings on OCT

  20. Findings on OCT • Results for a typical study patient at baseline, with a marked increase in retinal thickness caused by IR fluid, SR fluid, and sub-RPE fluid

  21. Findings on OCT • Small area of IR fluid, approximately equal to the median amount of fluid that was present in patients assigned to treatment as needed who did not receive treatment even though the reading-center graders identified fluid. • Lucentis as needed - 26.5% • Avastin as needed - 23.4%

  22. Findings on OCT • Retinal thickness at 12 months in a patient treated with ranibizumab monthly

  23. Findings on OCT • 12-month results for a patient who was treated with bevacizumab monthly

  24. Primary outcome results

  25. VA Outcomes at 1 Year

  26. Mean no. of letters at 1 Year

  27. Mean change in VA score from baseline

  28. Difference in mean change in VA score

  29. Secondary outcome results

  30. Change from baseline VA score

  31. Mean no. of treatments

  32. Average cost of drug/patient

  33. Mean change in total retinal thickness at the fovea during the first year of follow-up

  34. Fluid on OCT

  35. Dye leakage on FA

  36. Adverse Events Rates of death, MI, stroke were similar for either drug Serious AE were higher in Avastin (24.1%) vsLucentis (19.0%)

  37. Adverse Events within 1 Year

  38. Adverse Events within 1 Year

  39. Adverse Events within 1 Year

  40. Conclusions • Lucentis and Avastin, had equivalent effects on VA when administered according to the same schedule. • VA results could be achieve with less than monthly treatments. • Both reduce amount of fluid in or under the retina, but Lucentis patients showed a greater proportion of complete resolution of fluid. • Differences in rates of serious AE require further study.

  41. Impressions • Equivalent but no identicals. • Lucentis data appeared better in places. • No data to suggest that patients receiving Avastin need to be switch to Lucentis or viceversa. • Costs • Lucentis $2000/dose • Avastin $50/dose

  42. Impressions • Avastin with slightly higher risk of SAE? • Not clinically significant • Two year results may give further light on SAE differences • If concerned about SAE, Macugen is an option! • Monthly vs as-needed treatments • Compliance of office visits every 4 weeks • What about treat and extend? • Communication between physician and patient.

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