Avastin for Choroidal Neovascularization 2/2 ARMD


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Journal club review of Dr. Spaide's paper from Retina in 2006.

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Avastin for Choroidal Neovascularization 2/2 ARMD

  1. 1. INTRAVITREAL BEVACIZUMAB TREATMENT OF CHOROIDAL NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION Spaide RF, et al. Retina 2006; 26(4), 383-390. Terry J. Alexandrou, MD Department of Ophthalmology and Visual Science University of Chicago Journal Club
  2. 2. Purpose <ul><li>To describe the short-term anatomical and visual acuity responses after intravitreal injection of bevacizumab (Avastin, Genentech) in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). </li></ul>
  3. 3. Choroidal neovascularization secondary to Age-related macular degeneration <ul><li>A variety of methods have been used to stem the loss of vision by targeting the vascular portion of the lesion </li></ul><ul><ul><li>Thermal laser </li></ul></ul><ul><ul><li>PDT </li></ul></ul><ul><li>Agents that block the effects of vascular endothelial growth factor (VEGF) </li></ul><ul><ul><li>pegaptanib (macugen) - aptamer that targets only one of several splice lengths of VEGF (VEGF 165) </li></ul></ul>
  4. 4. Bevacizumab (Avastin, Genentech) <ul><li>A full-length antibody that binds all isoforms of VEGF </li></ul><ul><li>Was developed for the treatment of cancer </li></ul><ul><li>Bevacizumab is currently approved for use in humans but is labeled for cancer treatment </li></ul><ul><li>The full-length antibody has two binding sites for VEGF, while the antibody fragment has only one </li></ul>
  5. 5. Methods <ul><li>Retrospective study of 266 eyes of 266 patients with CNV secondary to ARMD who were treated with off-label intravitreal bevacizumab (avastin)(1.25 mg) </li></ul><ul><li>Institutional review board approval </li></ul><ul><li>Informed consent obtained from all patients (off-label use) </li></ul>
  6. 6. Methods <ul><li>Best-corrected distance visual acuity measurement with a Snellen chart </li></ul><ul><li>Ophthalmic examination including slit-lamp biomicroscopy </li></ul><ul><li>Baseline central retinal thickness was measured by optical coherence tomography (OCT) </li></ul><ul><li>Examined at 1 week and 1 month after the first injection and monthly thereafter </li></ul><ul><li>Fluorescein angiography was done at the discretion of the examiner </li></ul>
  7. 7. Statistical Analysis <ul><li>Data for all patients who received injections during the first 3 months of our use of bevacizumab were entered into a database </li></ul><ul><li>Visual acuity was converted to logMAR before analysis </li></ul><ul><li>[chi]2 testing </li></ul>
  8. 8. Main Outcome Measurements <ul><li>Visual acuity </li></ul><ul><li>Central retinal thickness measured by OCT </li></ul>
  9. 9. Results <ul><li>Mean age of the patients was 80.3 ± 7.5 years </li></ul><ul><li>Mean visual acuity was 20/184 </li></ul><ul><li>175 patients (69.7%) were previously treated </li></ul><ul><ul><li>139 (55.4%) had prior PDT with or without concomitant triamcinolone, </li></ul></ul><ul><ul><li>53 (21.1%) had previous pegaptanib treatment </li></ul></ul><ul><ul><li>43 (17.1%) had other treatments (anecortave acetate, thermal laser for nonsubfoveal lesions, and intravitreal triamcinolone without concomitant PDT) </li></ul></ul>
  10. 10. Results <ul><li>Baseline OCT was performed for 214 patients </li></ul><ul><ul><li>Mean central foveal thickness ± SD was 340 ± 206 µm </li></ul></ul><ul><ul><li>Cystoid macular edema was present in 120 patients (47.8%) </li></ul></ul>
  11. 11. Results – 1 month follow-up <ul><li>Mean visual acuity was 20/131 (P < 0.001), and 67 (33.5%) of patients had improvement in visual acuity as defined by a halving of the visual angle </li></ul><ul><li>Thirteen patients (6.1%) had worse visual acuity </li></ul><ul><li>Mean central macular thickness was 250 ± 190 µm </li></ul><ul><ul><li>n=170 </li></ul></ul><ul><ul><li>significantly less than the baseline finding (P < 0.001) </li></ul></ul><ul><li>Eighty percent of patients had a reduction of their central macular thickness at 1 month </li></ul><ul><li>2 patients had mild vitritis </li></ul><ul><ul><li>one of these patients had a history of previous recurrent uveitis before injection, and the other had spontaneous resolution by the 2-month follow-up </li></ul></ul>
  12. 12. Results – 2 and 3 month follow-up <ul><li>Mean visual acuity was 20/122 </li></ul><ul><li>At 2 months, 78 patients (31.1%) had better visual acuity, and 17 (8%) had worse visual acuity </li></ul><ul><li>At 3 months the mean visual acuity was 20/109; 54 patients (38.3%) had improved visual acuity, while 10 (4.7%) had worse vision (n = 141) </li></ul><ul><li>No endophthalmitis, increased intraocular pressure, retinal tears, or retinal detachment occurred in any patient </li></ul><ul><li>Patients previously treated with pegaptanib, PDT, or other forms of therapy had significant improvements in mean visual acuity and in mean central macular thickness at the 1-, 2-, and 3-month follow-ups </li></ul>
  13. 13. Results
  14. 14. Results – 78 y.o female with 2 previous macugen injections VA 20/50 After 2 avastin injections (1 month apart) VA 20/25
  15. 15. Results – 83 y.o female s/p 1 PDT and 3 macugen injections VA 20/200 VA 20/50 S/P 2 avastin injections (1 month apart)
  16. 16. Safety <ul><li>One patient developed a nonfatal myocardial infarction one month after the third injection </li></ul><ul><li>One patient died of metastatic breast cancer </li></ul><ul><li>One patient died of a myocardial infarction (76 y.o smoker with emphysema, single injection) </li></ul>
  17. 17. Conclusions <ul><li>Consecutive eyes with CNV secondary to AMD that were treated with intravitreal bevacizumab in this retrospective study had anatomical as well as functional improvement, even though most did not have a satisfactory response to previous treatment </li></ul><ul><li>>30% of patients having visual acuity improvement (defined as a halving of the visual angle at every time point measured in this short-term study). </li></ul>
  18. 18. Conclusions <ul><li>There was a prominent decrease in macular thickness as measured by OCT </li></ul><ul><li>There was no significant correlation between the change in macular thickness and the change in visual acuity </li></ul>
  19. 19. Study Limitations <ul><li>short-term follow-up </li></ul><ul><li>retrospective design </li></ul><ul><li>Nonrandomized </li></ul><ul><li>Uncontrolled </li></ul>
  20. 20. Discussion <ul><li>Difficult to assess the long-term efficacy of safety of bevacizumad based on this study, however these results are encouraging </li></ul>
  21. 21. Discussion <ul><li>At the time of this study, lucentis had not yet been approved. </li></ul><ul><li>These encouraging results warrant further investigation, especially given the enormous discrepancy in price between lucentis and avastin </li></ul>