• Ian Pearce, Sanjiv Banerjee, Ben J L Burton, Usha Chakravarthy, Louise Downey, Richard P Gale, Jonathan Gibson, Sergio Pagliarini, Jignesh Patel, Sobha Sivaprasad, Chris Andrews, Christopher Brittain, James Warburton, and RELIGHT Study Group.
• St. Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom. Electronic address: ian.pearce@rlbuht.nhs.uk.
• Ophthalmology. 2015 Sep 1; 122 (9): 1811-9.

PurposeTo evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in patients with visual impairment due to diabetic macular edema (DME).DesignA phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom.ParticipantsParticipants (N = 109) with visual impairment due to DME.MethodsParticipants received 3 initial monthly ranibizumab 0.5 mg injections (day 0 to month 2), followed by individualized best-corrected visual acuity (BCVA) and optical coherence tomography-guided re-treatment with monthly (months 3-5) and subsequent bimonthly follow-up (months 6-18). Laser was allowed after month 6.Main Outcome MeasuresMean change in BCVA from baseline to month 12 (primary end point), mean change in BCVA and central retinal thickness (CRT) from baseline to month 18, gain of ≥10 and ≥15 letters, treatment exposure, and incidence of adverse events over 18 months.ResultsOf 109 participants, 100 (91.7%) and 99 (90.8%) completed the 12 and 18 months of the study, respectively. The mean age was 63.7 years, the mean duration of DME was 40 months, and 77.1% of the participants had received prior laser treatment (study eye). At baseline, mean BCVA was 62.9 letters, 20% of patients had a baseline BCVA of >73 letters, and mean baseline CRT was 418.1 μm, with 32% of patients having a baseline CRT <300 μm. The mean change in BCVA from baseline to month 6 was +6.6 letters (95% confidence interval [CI], 4.9-8.3), and after institution of bimonthly treatment the mean change in BCVA at month 12 was +4.8 letters (95% CI, 2.9-6.7; P < 0.001) and +6.5 letters (95% CI, 4.2-8.8) at month 18. The proportion of participants gaining ≥10 and ≥15 letters was 24.8% and 13.8% at month 12 and 34.9% and 19.3% at month 18, respectively. Participants received a mean of 6.8 and 8.5 injections over 12 and 18 months, respectively. No new ocular or nonocular safety findings were observed during the study.ConclusionsThe BCVA gain achieved in the initial 6-month treatment period was maintained with an additional 12 months of bimonthly ranibizumab PRN treatment.Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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