Duration 5min, Q&A 3min
Impact of Ranibizumab Treatment with Bimonthly Monitoring on Patient-Reported Outcomes for Individuals with Diabetic Macular Edema Participating in the RELIGHT Study in the UK
Interim analysis of 12-month patient-reported vision-related functioning and treatment satisfaction outcomes from patients in the RELIGHT study of ranibizumab for the treatment of visual impairment due to diabetic macular oedema (DMO).
Patients enrolled in the prospective, open-label, multicentre, single-arm, 18-month RELIGHT Study (NCT01257815) were assessed at 20 UK clinical sites.
Patients with visual impairment due to DMO received three monthly initiation doses of ranibizumab 0.5 mg followed by individualized treatment as needed, with monthly follow-up for the first three months and subsequent follow-up every two months. Self-reported visual functioning and satisfaction with treatment were assessed using the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25; scored 0-100) and the 13-item Macular Disease Treatment Satisfaction Questionnaire (MacTSQ; scored 0-72), respectively. The NEI VFQ-25 was administered at months 0, 6, 12 and 18, and the MacTSQ at months 1, 6, 12 and 18. For both instruments, composite and subscale scores were calculated according to the developer's guidelines.
Results and Conclusion
Of 139 patients screened, 110 were treated. At enrolment the mean age was 64 years and 71% were male. The median number of treatments over 12 months was 7 (range, 3-9). At month 12, BCVA improved from a baseline mean of 62.6 letters to 67.8 (mean change, +5.2 letters). The mean NEI VFQ-25 composite score was 66.9 at baseline and increased by 6.0 points to 72.9 at month 12 (n = 99; p = 0.0004). Significant gains were reported in eight of eleven vision-related subscale scores, including general vision (+5.3; p = 0.011), near activities (+5.3; p = 0.017), distance activities (+6.4; p = 0.004) and mental health (+10.2; p < 0.001). The overall MacTSQ score increased from 62.1 at month 1 to 64.7 at month 6 (+2.6; n = 100; p < 0.001) and 66.7 at month 12 (+4.2; n = 98; p < 0.001). The increase in MacTSQ impact of treatment subscale score from baseline to month 12 was +3.4 (n = 98; p < 0.001).
The positive changes in the composite and individual subscale scores of the NEI VFQ-25 were generally in excess of the 5-point increases shown to reflect clinically significant differences in DMO and other ocular diseases. Our findings confirm improved patient functioning as a consequence of ranibizumab treatment in patients with DMO. The improvements in MacTSQ scores demonstrate the acceptability of the individualized treatment regimens of the RELIGHT study.
[ Keyword ]
Diabetic macular oedema / Ranibizumab / RELIGHT / Visual functioning / Treatment satisfaction
[ Conflict of Interest ]
[ Conflict of Interest (Potential conflict) ]
Usha Chakravarthy is Principal Investigator of trials sponsored by Novartis and has attended and been remunerated for attendance at advisory boards for Novartis, Bayer, Neovista, Oraya, Allergan, and Bausch and Lomb. Her employing institution has received payments from Novartis, Bayer, Neovista, Oraya, Alcon, and Pfizer. Ian Pearce lectures and has been a consultant with Novartis; he has no shares or other remuneration relevant to this abstract. Sanjiv Banerjee has been a consultant for Allergan, Bayer and Novartis. Richard Gale has received travel honoraria to investigator meetings, lecture fees and has been a consultant for Novartis. Jonathan Gibson has received travel honoraria and fees for attending advisory boards and conferences from Novartis, Bayer, Alimera, Allergan. The University of Aston has received research funding from Novartis for projects that he has initiated. He has no personal financial interest in any of the above companies.