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Efficacy and safety of ranibizumab in diabetic macular edema: real life study
Author(s) -
Hrarat L.,
Fajnkuchen F.,
Sarda V.,
Grenet T.,
Buffet S.,
Chaine G.,
Giocantiauregan A.
Publication year - 2015
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2015.0616
Subject(s) - medicine , ranibizumab , ophthalmology , visual acuity , fundus (uterus) , diabetic macular edema , macular edema , regimen , pro re nata , diabetic retinopathy , retrospective cohort study , clinical endpoint , surgery , diabetes mellitus , bevacizumab , randomized controlled trial , endocrinology , chemotherapy
Purpose To evaluate the efficacy and safety of ranibizumabin patients with vision loss secondary to diabetic macular edema ( DME ). Methods Retrospective analysis of a cohort of patients withvision loss ( VA ) due to DME and treated by ranibizumab. Patients were examined before treatment and during treatment every 4–6 weeks. Ophthalmologic examination included:measure of the best corrected visual acuity ( BCVA ) on the ETDRS scale, examination at the slit lamp, fundus, and SD ‐ OCT (Cirrus 5000, Carl Zeiss Meditec). All patients receiveda loading dose of 3 monthly injections followedby re‐treatments on an as‐needed basis ( PRN regimen) The primary endpoint was the change in visual acuity at 12 months. The other criteria assessed were central retinal thickness ( CRT ) after loading dose, and at 12 months, and the number ofintravitreal injections ( IVT ) during the first year of follow‐up. Results 109 eyes of 79 consecutive patients treateded since November 2012 have been included. At baseline the mean BCVA was 48.77 letters, the CRT was 517 microns. At 12 months the average BCVA was of 60.80 letters (p < 0.05), with an average VA gain of +14.67 letters and 25% of patients had a BCVA > 70 letters. The mean CRT after 3 injections was 344.32 microns (p < 0.05) and 332 microns (p < 0.05) at 12 months, with 57.23% of patients with CRT ≤ 300 microns. At 12 months the average VA in patients with CRT ≤ 300 microns was 63.51 letters (p < 0.05) and the average AV in patients with ERC > 300 .microns was 57.39 letters (p < 0.05). The average number of IVT performed during the first year of follow up was 5.59. No serious adverse event was noted. Conclusions Pivotal studies have clearly shown the benefit of ranibizumab treatment of vision loss due to DME . This study in a “real life” setting confirms the results obtained in randomized trials.