Duration 5min, Q&A 3min
The RELIGHT Study: Ranibizumab Treatment of Diabetic Macular Edema (DME) with Bimonthly Monitoring after a Phase of Initial Treatment; Final 18 Month Data
In patients with visual impairment due to DME (VI-DME) treated with ranibizumab 0.5mg, the 18-month RELIGHT study investigated whether extending follow-up intervals to bimonthly following initial monthly follow-up for 6 months, would provide and maintain improvements in vision.
110 DME patients were enrolled in the prospective, open-label, multicentre, single-arm, 18-month RELIGHT Study (NCT01257815) and were assessed at 20 UK clinical sites.
RELIGHT evaluated three initial monthly doses of ranibizumab 0.5mg, followed by individualised retreatment. Retreatment criteria were a reduction in VA of >5 letters and/or central retinal thickness (CRT)>225µm (according to OCT). Patients were monitored monthly for the first 6 months of the study, and then the monitoring period was extended to bi-monthly out to Month 18. Laser treatment was permitted after 6 months.
Results and Conclusion
At baseline, the median age of the patient population (n=110) was 64 years, mean VA was 63 letters and CRT was 422µm. Mean baseline duration of DME in the study eyes was 40 months, which is twice as long as the mean baseline DME duration of the RESTORE trial population, and may be more representative of actual UK DME patient populations. At Month 12 of the study, a mean VA gain of +5.0 letters was seen and this slightly increased by Month 18 to a mean VA gain of +6.5 letters. Similarly mean reduction in CRT at Month 12 was -127µm and this continued to decrease to a mean reduction of -150µm at Month 18. The 12-month median injection count was seven, increasing to nine by Month 18. No new ocular or non-ocular safety findings were observed during the 18 month period.
VA gains demonstrated at the 12-month primary endpoint of this 18-month study were maintained out to 18 months, following a total of 12 months of bi-monthly monitoring. It appears that extension of the monitoring regimen may be a feasible strategy in the management of some patients with VI-DME.
[ Keyword ]
DME / ranibizumab / bi-monthly
[ Conflict of Interest ]
[ Conflict of Interest (Potential conflict) ]
The study was sponsored by Novartis Pharmaceuticals Uk Ltd who participated in the design and conducting of the study; data collection, management, analysis, and interpretation; and preparation and review of the abstract.