Abstract
Purpose: :
To describe the evolution of visual acuity, measured by ETDRS, in patients with wet age-related macular degeneration (wAMD) treated with ranibizumab in current practice over a period of 12 months.
Methods: :
Retrospective observational study sponsored by Novartis. A representative sample of 16 investigators selected by an external company on activity and geography criteria included 551 eyes of consecutive patients with wet AMD.
Results: :
At baseline, most patients were female (63.2%), their mean age was 78.2 ± 7.1 years and their visual acuity 53.2 ± 19.3 letters. The achievement was mostly pure occult (54.7%). The initial assessment included a fluorescein angiography in 84.2% of cases, indocyanine green in 28.9% of cases, optical coherence tomography (OCT) in 88.2% of cases. Only 39.6% of patients received an induction phase with the first 3 injections every 4-5 weeks. No patient had a strict monthly monitoring over 12 months (visits every 30 days + / - 7 days). Only 4.4% of patients underwent "regular" follow-up (visits every 37 days + / - 14 days). The average visits number was 8.6 ± 2.0 (with 5.7 ± 1.6 from the third month) for an average of 5.1 ± 2.1 injections (2.5 ± 1, 9 from the third month). At 12 months, the visual acuity gain was 3.2 ± 14.8 letters, without any difference whether the patient has received or not an induction phase. Occult type had a visual acuity gain of 2.4 ± 15.0 letters at one year and predominantly classic type 6.3 ± 14.9. However, the visual acuity gain at 3 months was an average of 5.3 ± 11.9 letters and was greater in the group receiving induction (6.7 ± 13.1 letters) than in not qualifying for them (4.3 ± 10.9 letters p = 0.065, NS). 19.6% of patients gained 15 or more letters at 12 months.
Conclusions: :
A visual acuity gain was observed under treatment, in real conditions of exercise. However, the study suggests a lack of monitoring patients in France. The failure of conventional regimen (induction phase followed by monthly checks) of ranibizumab probably explains why the visual results are lower than those of prospective studies. This study confirms the importance of strict monthly monitoring to ensure that patients gain maximum visual acuity.
Keywords: age-related macular degeneration • vascular endothelial growth factor • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials