Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment 18-Month, Multicenter, Phase IIIB RELIGHT Study

作者：Pearce Ian^*; Banerjee Sanjiv; Burton Ben J L; Chakravarthy Usha; Downey Louise; Gale Richard P; Gibson Jonathan; Pagliarini Sergio; Patel Jignesh; Sivaprasad Sobha; Andrews Chris; Brittain Christopher; Warburton James

来源：Ophthalmology, 2015, 122(9): 1811-1819.

DOI：10.1016/j.ophtha.2015.05.038

Purpose: To 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).
Design: A phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom.
Participants: Participants (N = 109) with visual impairment due to DME.
Methods: Participants 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 tomographyeguided re-treatment with monthly (months 3-5) and subsequent bimonthly follow-up (months 6-18). Laser was allowed after month 6.
Main Outcome Measures: Mean 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.
Results: Of 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 mu m, with 32% of patients having a baseline CRT < 300 mu m. 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.
Conclusions: The BCVA gain achieved in the initial 6-month treatment period was maintained with an additional 12 months of bimonthly ranibizumab PRN treatment.

• 出版日期2015-9