June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
The LUCIDATE study: a randomized clinical trial to evaluate the long-term functional and anatomical effects of repeated ranibizumab therapy compared with laser in diabetic macular edema
Author Affiliations & Notes
  • Oliver Comyn
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Tunde Peto
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Catey Bunce
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Magella Neveu
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Graham Holder
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Praveen Patel
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Catherine Egan
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • James Bainbridge
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Philip Hykin
    NIHR Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom
  • Footnotes
    Commercial Relationships Oliver Comyn, Novartis (F), Novartis (R); Tunde Peto, None; Catey Bunce, None; Magella Neveu, None; Graham Holder, Servier (C); Praveen Patel, Allergan (R), Bayer (C), Novartis UK (C), Heidelberg UK (R), Topcon UK (R), Thrombogenics (C); Catherine Egan, Bayer (S), Oculogics (S), Novartis (S), Allergan (S), Novartis (F); James Bainbridge, Novartis (F), Alimera (C), Gene Signal (C), Advanced Cell Technology (F), Targeted Genetics (P), Oxford Biomedica (C), GSK (F); Philip Hykin, BAYER (C), NOVARTIS (C), ALLERGAN (C), BAYER (R), NOVARTIS (R), ALLERGAN (F), NOVARTIS (F)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 2390. doi:
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      Oliver Comyn, Tunde Peto, Catey Bunce, Magella Neveu, Graham Holder, Praveen Patel, Catherine Egan, James Bainbridge, Philip Hykin; The LUCIDATE study: a randomized clinical trial to evaluate the long-term functional and anatomical effects of repeated ranibizumab therapy compared with laser in diabetic macular edema. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2390.

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

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Abstract
 
Purpose
 

To determine the effect of repeated ranibizumab treatment on retinal function and morphology associated with diabetic macular edema (DME) and to identify factors that may be associated with a favourable treatment response.

 
Methods
 

Randomized controlled trial. 36 subjects with center-involving DME, BCVA 55-79 ETDRS letters, OCT central retinal thickness >300 µm and moderate macular ischemia only were randomized 2:1 to receive ranibizumab 0.5 mg (3 initial 4-weekly injections then prn retreatment) or modified ETDRS laser (at baseline and every 12 weeks if CSME present). Criteria included a foveal avascular zone (FAZ) <1000 µm and perifoveal capillary loss less than severe. Subjects underwent best-corrected ETDRS visual acuity, fluorescein angiography; Spectralis OCT; Nidek MP1 microperimetry; ChromaTest color contrast sensitivity; and pattern, full-field and multifocal electroretinography at baseline, 12, 24 and 48 weeks (primary endpoint for exploratory outcomes). Masked graders evaluated angiographic images for FAZ characteristics and OCT scans for the presence of retinal fluid, hyperreflective foci, outer retinal disruption and vitreomacular interface abnormalities.

 
Results
 

33 patients completed 48 weeks follow up. Ranibizumab-treated subjects gained 6.0 ETDRS letters while laser subjects lost 0.9 letters (p=0.008). FAZ area increased from baseline to 48 weeks in ranibizumab-treated subjects by 0.113 ±0.124 mm2 and by 0.153 ±0.078 mm2 in laser treated subjects (p=0.34). At 48 weeks, external limiting membrane was more likely to be present than interrupted in the ranibizumab group than the laser group (45% vs 0%, p=0.013). Retinal sensitivity improved in the central 4° by 3.2 dB in the ranibizumab group and by 1.9 dB in the laser group. Tritan color contrast threshold improved from 81% to 70% (ranibizumab) and from 89% to 86% (laser). PERG P50 amplitude decreased in laser-treated subjects by 10.7% at 48 weeks and remained constant for ranibizumab-treated subjects. Other electrophysiological parameters showed no significant changes.

 
Conclusions
 

This exploratory study has shown a trend towards greater improvements in visual function with ranibizumab therapy than with laser for DME, without evidence of increased macular ischemia. These findings can be used to inform the design of larger clinical trials.

 
Keywords: 499 diabetic retinopathy • 748 vascular endothelial growth factor • 688 retina  
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