June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
One-year outcomes of ranibizumab treatment in a cohort of patients with retinal vein occlusion: an interim analysis from the real-world LUMINOUS study
Author Affiliations & Notes
  • Ian A Pearce
    St Paul’s Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom
  • Ayan Das Gupta
    Novartis Pharma, Hyderabad, India
  • Sue Lacey
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships Ian Pearce, Alcon (C), Alcon (R), Allergan (C), Allergan (R), Bayer (C), Bayer (F), Bayer (R), Novartis (C), Novartis (F), Novartis (R); Ayan Das Gupta, Novartis (E); Sue Lacey, Novartis (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 3743. doi:
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      Ian A Pearce, Ayan Das Gupta, Sue Lacey, ; One-year outcomes of ranibizumab treatment in a cohort of patients with retinal vein occlusion: an interim analysis from the real-world LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3743.

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

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Abstract
 
Purpose
 

Ranibizumab is approved for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion [RVO; branch (BRVO) or central (CRVO)] in many countries worldwide. However, there are limited data on its use in RVO patients in a real-world setting. We present the preliminary baseline characteristics of RVO patients enrolled before March 2014 and 1-year results of RVO patients enrolled into the LUMINOUS study before March 2013.

 
Methods
 

LUMINOUS (NCT01318941) is an ongoing 5-year, global, multicenter, prospective, observational study designed to evaluate the long-term safety, effectiveness, treatment patterns and health-related quality-of-life outcomes associated with ranibizumab 0.5 mg treatment in clinical practice. Consenting adult RVO patients, treatment naïve or those previously treated with ranibizumab/other ocular treatments, were treated according to the local product label.

 
Results
 

At baseline BRVO/CRVO patients (N=393/350) had a mean age of 69.0/68.2 years, 54.2/44.0% were female, and 82.7/84.3% were Caucasian. The baseline mean visual acuity (VA, ETDRS letters, primary treated eye) for BRVO/CRVO was 52.0/43.1 in treatment naïve patients and 58.2/49.8 in patients previously treated with ranibizumab. One-year follow-up data were available for 119 patients each for BRVO/CRVO. The patients who completed 1 year (BRVO/CRVO) showed mean VA (letters) gains of 7.0/13.2 (n=7/15) in treatment naïve patients and 8.0/1.4 (n=20/16) in those previously treated with ranibizumab (Figure). The VA gains were observed with a relatively low mean number of injections and monitoring visits (BRVO/CRVO: treatment naïve, 3.6/3.8 injections and 5.8/5.3 monitoring visits; previously treated with ranibizumab, 3.7/3.3 injections and 6.2/5.8 monitoring visits). The rates of ocular and non-ocular serious adverse events were 1.3% and 3.8%, respectively (Table).

 
Conclusions
 

At one year, ranibizumab 0.5 mg treatment led to improvement or maintenance of VA outcomes in RVO patients irrespective of pre-treatment status, with a low mean number of injections and monitoring visits. Outcomes from this interim analysis of the LUMINOUS study reinforce the well-established safety and efficacy profile of ranibizumab in RVO.  

 
Figure. Mean VA outcomes and treatment exposure over one year
 
Figure. Mean VA outcomes and treatment exposure over one year
 
 
Table. Serious adverse events reported at one year (BRVO and CRVO)
 
Table. Serious adverse events reported at one year (BRVO and CRVO)

 
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