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Original article
Patient-reported outcomes in the RELIGHT clinical trial of ranibizumab in diabetic macular oedema
  1. Usha Chakravarthy1,
  2. Ian Pearce2,
  3. Sanjiv Banerjee3,
  4. Benjamin J L Burton4,
  5. Louise Downey5,
  6. Richard Gale6,
  7. Jignesh Patel7,
  8. Sudeshna Patra8,
  9. Sobha Sivaprasad9,
  10. Michael Stevenson10,
  11. Susanne Lupton11
  12. On behalf of the RELIGHT study group
  1. 1Departmentof Ophthalmology, Queens University, Belfast, UK
  2. 2St Paul’s Eye Unit, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
  3. 3University Hospital of Wales, Cardiff, UK
  4. 4Departmentof Ophthalmology, James Paget University Hospital, Great Yarmouth, UK
  5. 5Department of Ophthalmology, Hull Royal Infirmary, Hull, UK
  6. 6Departmentof Ophthalmology, The York Hospital UK, York, UK
  7. 7Essex County Hospital, Colchester, UK
  8. 8Whipps Cross University Hospital, London, UK
  9. 9NIHR Moorfields Biomedical Research Centre, London, UK
  10. 10Medical Education, Queens University of Belfast, Belfast, UK
  11. 11Departmentof Ophthalmology, Novartis Pharma UK, Frimley, UK
  1. Correspondence to Dr Usha Chakravarthy; U.Chakravarthy{at}qub.ac.uk

Abstract

Background/aims The RELIGHT clinical trial used an individualised treatment regimen of ranibizumab to treat diabetic macular oedema (DMO). We report findings from two patient-reported outcome instruments.

Methods The National Eye Institute Visual Function Questionnaire (NEI-VFQ) was administered before starting treatment (M0) and at M6, 12 and 18. The Macular Disease Society Treatment Satisfaction Questionnaire (MacTSQ) was administered 1 month after treatment start (M1) and at M6, 12 and 18. Relationships between best-corrected visual acuity (BCVA) in the study eye (SE) and the status of the eye at baseline (as better or worse eye by BCVA) and the two instrument measures were investigated.

Results BCVA in the SE correlated strongly with the NEI-VFQ composite scores and the majority of the subscales but not with the MacTSQ subscales. Statistically significant improvements were observed in the majority of the subscales of the NEI-VFQ at M6, 12 and 18. For the MacTSQ, improvements between baseline M6, 12 and 18 were seen for subscale 1 but only reached statistical significance at M12. In subscale 2, the changes in mean scores were statistically significant at all timepoints.

Conclusions Although ranibizumab treatment in DMO over an 18-month period resulted in improvements in visual functioning and patient satisfaction, no correlation was found between the instruments used to measure these outcomes. Our finding of a lack of correlation between BCVA and the MacTSQ suggests the presence of psychophysical factors not measured by traditional means.

  • vision
  • clinical trial
  • drugs
  • macula
  • retina

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjophth-2018-000226

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    Footnotes

    • Contributors UC, IP, SB, BJLB, LD, RG, JP, SP and SS were involved in patient enrolment, history taking, clinical examination, data collection and interpretation. UC, MS and SL developed and performed additional statistical analysis of the core data. UC developed the initial manuscript outline which was further developed and reviewed by IP, SB, BJLB, LD, RG, JP, SP, SS and SL. SL provided medical writing and project management services.

    • Funding This study was funded by Novartis Pharmaceutical UK Ltd, who had full control of the study design. However, the hrQOL information including the entire dataset was provided to MS, the nominated statistician at Queen’s University who had full control of the data for the hrQOL analysis.

    • Competing interests UC reports grants and personal fees from Novartis and Bayer Pharma. IP reports lecture fees and consulting fees from Novartis. RG reports lecture fees and grants from Novartis. SS reports grants and personal fees from Novartis, Bayer, Roche, Boehringer Ingelheim, Optos and Heidelberg. LD reports personal fees from Novartis, Bayer, Alimera and Allergan. BJLB reports grants and research funding from Novartis Pharma. SP reports other from Novartis, Bayer, Allergan and Alimera. SL reports other from Novartis. JP and SB have nothing to disclose.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.