One-year outcome of ranibizumab for neovascular age-related macular degeneration: a thorough analysis in a real-world clinical setting.
OBJECTIVE
To verify the safety and efficacy of ranibizumab in neovascular age-related macular degeneration (nAMD) and factors influencing the outcome in a real-world setting.


METHODS
Retrospective 12-month follow-up analysis of 100 naive nAMD eyes treated with as-needed ranibizumab. Changes in best-corrected visual acuity (BCVA), central retinal thickness (CRT), lesion, and leakage size were recorded. Type and characteristics of lesions and indicators of protocol adherence were analyzed.


RESULTS
Mean BCVA at baseline was 61.6 ± 14.8 Early Treatment Diabetic Retinopathy Study letters and 59.6 ± 16 at 12 months. Sixty-three eyes maintained or improved BCVA; the number of injections and follow-up visits were 4.8 and 5.1, respectively. First injection and pro re nata retreatments were administered 22.7 and 20.5 days after prescription, respectively. Seventy-two eyes received 3 initial monthly injections. Patients were not reinjected despite BCVA loss >5 letters one or more times in 37% of cases. No adverse events were reported. The CRT diminished by 26 ± 101 μm; choroidal neovascularization size and leakage area increased by 0.53 ± 1.31 mm² and 0.34 ± 1.33 mm², respectively. The BCVA gain was correlated with CRT reduction (r = 0.24, p = 0.016), mean baseline BCVA (r = -0.25, p = 0.01), age (r = -0.25, p = 0.01), and decrease in CNV size and leakage area (r = 0.56 and r = 0.59, respectively, p<0.001).


CONCLUSIONS
Our results compare unfavorably with those of controlled trials. Treatment and follow-up regimens in real-world settings seem to have a major role in determining outcome. Lower age and BCVA at baseline were associated with better response to treatment.
1 Department of Ophthalmology, University of Udine, Udine - Italy.
Andrea
A
Gabai
Daniele
D
Veritti
Paolo
P
Lanzetta
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab; D012160:Retina / Q000473:pathology; D019233:Retreatment; D012189:Retrospective Studies; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology; D057135:Wet Macular Degeneration / Q000188:drug therapy / Q000503:physiopathology
D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab