September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Efficacy of ranibizumab treatment in retinal vein occlusion patients with retinal macular ischemia: 24-month data from BRIGHTER and CRYSTAL
Author Affiliations & Notes
  • Jordi Mones
    Tissue Engineering and Stem Cell Group, Institut de la Macula de la Retina, Barcelona, Spain
  • Footnotes
    Commercial Relationships   Jordi Mones, Alcon (F), Alcon (C), Alimera (C), Allergan (C), Bayer (F), Bayer (C), Genentech (F), Genentech (C), Notal Vision (I), Notal Vision (C), Novartis (F), Novartis (C), Novartis (R), Ophthotech (F), Ophthotech (I), Ophthotech (C), Roche (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 5157. doi:
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      Jordi Mones; Efficacy of ranibizumab treatment in retinal vein occlusion patients with retinal macular ischemia: 24-month data from BRIGHTER and CRYSTAL. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5157.

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

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Abstract

Purpose : To date, there is limited evidence on the effect of retinal macular ischemia on visual acuity (VA), prognosis, and disease management in patients with retinal vein occlusion (RVO). Here we report the efficacy of ranibizumab treatment and impact of retinal macular ischemia on best-corrected VA (BCVA) outcomes over 24 months in branch RVO (BRVO) and central RVO (CRVO) patients from BRIGHTER and CRYSTAL studies, respectively.

Methods : The 24-month, phase IIIb, multicenter BRIGHTER (randomized; NCT01599650) and CRYSTAL (single-arm; NCT01535261) studies assessed the long-term efficacy and safety of individualized stabilization criteria-driven pro re nata dosing regimen of ranibizumab 0.5 mg. BRIGHTER and CRYSTAL allowed enrollment of BRVO and CRVO patients, respectively with retinal macular ischemia at baseline. One exploratory endpoint was the mean change in BCVA from baseline to Month 24 based on baseline ischemic status, severity and location of the ischemia. Retinal macular ischemia in both studies was defined as capillary loss (mild, moderate, severe or completely destroyed) in at least one location of the centre, inner or outer subfields based on Early Treatment Diabetic Retinopathy Study (ETDRS) grading and assessed by the Vienna central reading center (CRC).

Results : In BRIGHTER, 48.3%, 39.9% and 45.6% of patients in the ranibizumab, ranibizumab with laser, and laser monotherapy groups, respectively, had retinal macular ischemia at baseline, as assessed by the CRC. At Month 24, for ischemic/non-ischemic BRVO patients, a mean BCVA gain of >13 letters was observed in all treatment groups (Table), with the exception of non-ischemia patients treated with laser monotherapy (+5.9 letters). In CRYSTAL, approximately, 30% of patients had retinal macular ischemia at baseline, as assessed by the CRC. At Month 24, there was a mean BCVA gain of 11.1/12.9 letters for ischemic/non-ischemic CRVO patients. There were mean BCVA letter gains irrespective of severity and location of the ischemia in both BRVO and CRVO patients at Month 24 (Table).

Conclusions : Findings from BRIGHTER and CRYSTAL demonstrate that patients with BRVO and CRVO can achieve improved BCVA gains over 24 months, regardless of their baseline retinal macular ischemia status. The severity and location of the ischemia does not impact on BCVA outcomes.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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