Ranibizumab 0.5 mg for XXXX with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study.

@entity1 @entity227 @entity1103
PURPOSE: To evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in @entity1 with @entity227 due to @entity1103 ( @entity1103 ). DESIGN: A phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom. @entity1 : @entity1 (N  = 109) with @entity227 due to @entity1103 . METHODS: @entity1 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 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 @entity1 , 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 @entity1103 was 40 months, and 77.1% of the @entity1 had received prior laser treatment (study eye). At baseline, mean BCVA was 62.9 letters, 20% of @entity1 had a baseline BCVA of >73 letters, and mean baseline CRT was 418.1  m, with 32% of @entity1 having a baseline CRT <300  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 @entity1 gaining >= 10 and >= 15 letters was 24.8% and 13.8% at month 12 and 34.9% and 19.3% at month 18, respectively. @entity1 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.
