Ranibizumab

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Promising drug in treating wet macular degeneration by intraocular injection. [1][2][3]. It is also being developed for macula oedema due to retinal vein occlusion with the BRAVO, CRUISE trials having reported 6 month followup suggesting benefit[4] and in diabetic maculopathy with the RESTORE trial reporting positive results[5]. A modified recombinant monoclonal antibody.

Model of relative effectiveness normalising data from two separate trials with different populations so the sham data may not relate that well to Verteporfin

Contents

Indications

  • Treatment of neovascular (wet) AMD
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Ranibizumab, within its marketing authorisation, is recommended as an option for the treatment of wet age-related macular degeneration if:

  • all of the following circumstances apply in the eye to be treated:
    • the best-corrected visual acuity is between 6/12 and 6/96
    • there is no permanent structural damage to the central fovea
    • the lesion size is less than or equal to 12 disc areas in greatest linear dimension
    • there is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes)

and

  • the cost of ranibizumab beyond 14 injections in the treated eye is met by the manufacturer[6]

Issues

There were preliminary reports of increased stroke risk at higher doses [7]. In later work bevacizumab and ranibizumab use was not associated with increased risks of mortality, myocardial infarction, bleeding, or stroke compared with photodynamic therapy or pegaptanib[8]. It may be safer with respect to arterial thrombotic events and severe intraocular inflammation than bevacizumab[9] which is unlicensed for this indication but cheaper and widely used[10]. If it was used systemically it might have as a side effect osteonecrosis.

Side-effects

References

  1. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. The New England journal of medicine. 2006;355:1419-31. (Direct link – subscription may be required.)
  2. Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. The New England journal of medicine. 2006;355:1432-44. (Direct link – subscription may be required.)
  3. Ferrara N, Damico L, Shams N, Lowman H, Kim R. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina (Philadelphia, Pa.) 2006;26:859-70. (Direct link – subscription may be required.)
  4. Garnock-Jones KP. Ranibizumab: in macular oedema following retinal vein occlusion. Drugs. 2011 Mar 5; 71(4):455-63.(Link to article – subscription may be required.)
  5. Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A. The RESTORE Study Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr; 118(4):615-25.(Link to article – subscription may be required.)
  6. NICE TA155 Pegaptanib and ranibizumab for the treatment of age-related macular degeneration August 2008
  7. Reuters report on stroke risk
  8. Curtis LH, Hammill BG, Schulman KA, Cousins SW. Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration. Archives of ophthalmology. 2010 Oct; 128(10):1273-9.(Link to article – subscription may be required.)
  9. Carneiro AM, Barthelmes D, Falcão MS, Mendonça LS, Fonseca SL, Gonçalves RM, Faria-Correia F, Falcão-Reis FM. Arterial thromboembolic events in patients with exudative age-related macular degeneration treated with intravitreal bevacizumab or ranibizumab. Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift für Augenheilkunde. 2011; 225(4):211-21.(Link to article – subscription may be required.)
  10. Meyer CH, Holz FG. Preclinical aspects of anti-VEGF agents for the treatment of wet AMD: ranibizumab and bevacizumab. Eye (London, England). 2011 Apr 1.(Epub ahead of print) (Link to article – subscription may be required.)
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