Peter A Campochiaro1, Charles C Wykoff2, Michael Singer3, Robert Johnson4, Dennis Marcus5, Linda Yau6, Gary Sternberg6. 1. The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: pcampo@jhmi.edu. 2. Retina Consultants Houston, Houston, Texas. 3. Medical Center Ophthalmology Associates, San Antonio, Texas. 4. Department of Ophthalmology, California Pacific Medical Center, San Francisco, California. 5. Southeast Retina Center, Augusta, Georgia. 6. Genentech, Inc., South San Francisco, California.
Abstract
OBJECTIVE: To compare pro re nata (PRN) and monthly injections of 0.5 mg ranibizumab in retinal vein occlusion (RVO) patients stabilized by monthly injections. DESIGN: Randomized, open-label, vision-examiner masked, 15-month study. PARTICIPANTS: Subjects with macular edema secondary to branch or central RVO. METHODS: Subjects received monthly injections of 0.5 mg ranibizumab for 7 months and those meeting stability criteria between months 7 and 14 were randomized (1:1) to PRN injections versus continued monthly injections. Non-randomized (NR) subjects (never met stability criteria) received monthly injections. MAIN OUTCOME MEASURES: The primary endpoint was the slope of change in best-corrected visual acuity (BCVA) between months 7 and 15. RESULTS: There was no significant difference in the slope of change in BCVA between months 7 and 15 in patients treated PRN versus those treated with monthly injections (P = 0.509). Mean (± standard deviation) change from baseline BCVA in Early Treatment Diabetic Retinopathy Study letter score at month 15 was 21.0 ± 14.1 in the PRN group (n = 82) versus 18.7 ± 14.1 in the monthly group (n = 80) and 14.5 ± 14.7 in NR subjects (n = 13). The percentage of subjects who achieved BCVA ≥ 20/40 at month 15 was 76.8% in the PRN group, 71.3% in the monthly group, and 46.2% in NR subjects. The mean (± standard deviation) change from baseline central subfield thickness was -247.8 ± 207.5 μm in the PRN group, -289.9 ± 177.2 μm in the monthly group, and -93.2 ± 225.2 μm in NR subjects. There were no significant differences in mean BCVA gains or central subfield thickness reductions at month 15 between the PRN and monthly injection groups (all > 0.05). CONCLUSIONS: After edema resolution from 7 or more monthly ranibizumab injections in RVO subjects, visual outcomes at month 15 were excellent and not significantly different in subjects treated PRN versus those who continued monthly injections.
RCT Entities:
OBJECTIVE: To compare pro re nata (PRN) and monthly injections of 0.5 mg ranibizumab in retinal vein occlusion (RVO) patients stabilized by monthly injections. DESIGN: Randomized, open-label, vision-examiner masked, 15-month study. PARTICIPANTS: Subjects with macular edema secondary to branch or central RVO. METHODS: Subjects received monthly injections of 0.5 mg ranibizumab for 7 months and those meeting stability criteria between months 7 and 14 were randomized (1:1) to PRN injections versus continued monthly injections. Non-randomized (NR) subjects (never met stability criteria) received monthly injections. MAIN OUTCOME MEASURES: The primary endpoint was the slope of change in best-corrected visual acuity (BCVA) between months 7 and 15. RESULTS: There was no significant difference in the slope of change in BCVA between months 7 and 15 in patients treated PRN versus those treated with monthly injections (P = 0.509). Mean (± standard deviation) change from baseline BCVA in Early Treatment Diabetic Retinopathy Study letter score at month 15 was 21.0 ± 14.1 in the PRN group (n = 82) versus 18.7 ± 14.1 in the monthly group (n = 80) and 14.5 ± 14.7 in NR subjects (n = 13). The percentage of subjects who achieved BCVA ≥ 20/40 at month 15 was 76.8% in the PRN group, 71.3% in the monthly group, and 46.2% in NR subjects. The mean (± standard deviation) change from baseline central subfield thickness was -247.8 ± 207.5 μm in the PRN group, -289.9 ± 177.2 μm in the monthly group, and -93.2 ± 225.2 μm in NR subjects. There were no significant differences in mean BCVA gains or central subfield thickness reductions at month 15 between the PRN and monthly injection groups (all > 0.05). CONCLUSIONS: After edema resolution from 7 or more monthly ranibizumab injections in RVO subjects, visual outcomes at month 15 were excellent and not significantly different in subjects treated PRN versus those who continued monthly injections.
Authors: Maria-Magdalena Guichard; Anton R Xavier; Cengiz Türksever; Christian Pruente; Katja Hatz Journal: Ophthalmic Res Date: 2018-03-22 Impact factor: 2.892