April 2009
Volume 50, Issue 13
ARVO Annual Meeting Abstract  |   April 2009
Visual Acuity Recovery After a Single Ranibizumab Re-treatment in Patients of the SUSTAIN Study During PRN Treatment
Author Affiliations & Notes
  • A. Weichselberger
    Novartis Pharma AG, Basel, Switzerland
  • P. Mitchell
    Eye Clinic Westmead Hospital, Westmead, Australia
  • K.-U. Bartz-Schmidt
    Universitätsklinikum Tübingen, Augenklinik, Tübingen, Germany
  • F. Holz
    Universität-Klinikum, Augenklinik, Bonn, Germany
  • Footnotes
    Commercial Relationships  A. Weichselberger, Novartis, E; P. Mitchell, Novartis, C; K.-U. Bartz-Schmidt, Novartis, F; F. Holz, Novartis, C.
  • Footnotes
    Support  This study was sponsored by Novartis Pharma
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 2364. doi:
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      A. Weichselberger, P. Mitchell, K.-U. Bartz-Schmidt, F. Holz, on behalf of the SUSTAIN study group; Visual Acuity Recovery After a Single Ranibizumab Re-treatment in Patients of the SUSTAIN Study During PRN Treatment. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2364.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To describe the extent of best-corrected visual acuity (BCVA) recovery after a single ranibizumab retreatment in SUSTAIN study patients who followed a PRN regimen from Month 3 onwards.

Methods: : In the open-label, multi-center, single-arm SUSTAIN study of 12 months duration, 513 patients with age-related macular degeneration (AMD) received 3 initial monthly injections of ranibizumab (0.3 mg) and re-treatment with ranibizumab (0.3/0.5 mg) in the maintenance phase when they either lost >5 letters in BCVA or their central retinal thickness (CRT) increased by >100 µm, with the option not to treat when CRT ≤ 225 µm or BCVA ≥ 79 letters. The response to a single injection during the maintenance phase was analyzed under different conditions regarding AMD characteristics, demographics, treatment, and response history.

Results: : Based on an interim analysis of 69 patients, patients who lost >5 letters of BCVA in the maintenance phase responded to the subsequent ranibizumab injection with an average BCVA gain of about 3 letters. For approx. half of these patients this injection took place after at least 4 months without treatment. Results of the entire patient population will also be presented. BCVA gain correlates stronger to the short-term loss than to the overall loss of visual acuity.

Conclusions: : The results suggest that in patients whose BCVA decreased by >5 letters after the loading phase, a single injection of ranibizumab in the maintenance phase can bring back vision in a magnitude similar to what is seen for the initial injection at baseline.

Clinical Trial: : www.clinicaltrials.gov NCT00331864

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • visual acuity 

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