April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Ranibizumab treatment of diabetic macular edema with bimonthly monitoring: 18-month outcomes of the Phase IIIb multicenter RELIGHT study
Author Affiliations & Notes
  • Ian A Pearce
    St Pauls Eye Unit, Royal Liverpool Univ Hosp, Liverpool, United Kingdom
  • Footnotes
    Commercial Relationships Ian Pearce, Bayer (C), Novartis (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 1701. doi:
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    • Get Citation

      Ian A Pearce, ; Ranibizumab treatment of diabetic macular edema with bimonthly monitoring: 18-month outcomes of the Phase IIIb multicenter RELIGHT study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1701.

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

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Abstract
 
Purpose
 

In Europe ranibizumab 0.5 mg is licensed for visual impairment due to diabetic macular edema (VI-DME) using a pro re nata dosing regimen addressing individual patient needs with reduced treatment burden; however, the product information recommends monthly monitoring and retreatment primarily based on visual acuity (VA). RELIGHT investigates the impact of bimonthly follow-up and individualized retreatment, after a monthly follow-up for 6 months (M) on maintaining improvements in best-corrected visual acuity (BCVA).

 
Methods
 

RELIGHT was an 18M, prospective, open-label, multicenter, single-arm, phase IIIb, UK study. Patients received three initial monthly ranibizumab injections (Day0-M2), followed by individualized VA- and optical coherence tomography (OCT)-guided retreatment with monthly (M3-M5), and subsequent bi-monthly follow-up (M6-M18). Key outcome measures: mean change in BCVA from baseline-M12 (primary), mean change in BCVA and central retinal thickness (CRT) from baseline-M18, gain of ≥10 and ≥15 letters, and incidence of adverse events over 18M.

 
Results
 

Overall, 99 (90.8%) of 109 enrolled patients completed the study, with a mean duration of DME of 40M. Mean baseline BCVA was 62.9 letters and 77.1% of patients had received prior laser treatment. Mean change in BCVA was +4.9 letters (M12) and +6.5 letters (M18) achieved with a mean of 6.8 and 8.5 injections, respectively. CRT decreased from −127µm (M12) to −150µm (M18). The proportion of patients gaining ≥10 and ≥15 letters were 24.8% and 13.8% at M12 and 35% and 19% at M18, respectively. A subgroup analysis on BCVA based on the duration of DME shows that patients with shorter duration of DME (<3M, >3-<12M; Figure 1) achieve greater BCVA improvements compared to patients with a longer duration of DME >12M). No new safety findings were reported.

 
Conclusions
 

VA gains were maintained with a bimonthly monitoring regimen over 12M, offering a regimen with a lower number of monitoring visits as a viable option for the long term management of some patients with VI-DME. Duration of DME influences VA outcome.

 
 
BCVA gain from baseline at Months 12 and 18 by duration of DME
 
BCVA gain from baseline at Months 12 and 18 by duration of DME
 
Keywords: 499 diabetic retinopathy • 609 neovascularization • 585 macula/fovea  
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