Giocanti-Aurégan Audrey, Hrarat Linda, Qu Lise M, Sarda Valérie, Boubaya Marouane, Levy Vincent, Chaine Gilles, Fajnkuchen Franck
Department of Ophthalmology, Hôpital Avicenne, Bobigny, France 2Départment Hospitalo-Universitaire (DHU) Vision et Handicap, Department of Ophthalmology, Hôpital Pitié-Salpêtrière, Paris, France.
Clinical Research Unit, Paris Seine Saint Denis University Hospitals, Bobigny, France.
Invest Ophthalmol Vis Sci. 2017 Feb 1;58(2):797-800. doi: 10.1167/iovs.16-20855.
To assess the effect of serous retinal detachment (SRD) on functional and anatomical outcomes in ranibizumab-treated patients with diabetic macular edema (DME).
All consecutive ranibizumab-treated patients with SRD were included in this retrospective study. For each patient with SRD, a patient without SRD with the same baseline best-corrected visual acuity (BCVA) was randomly included for adjustment on their baseline BCVA. All patients with SRD were included in group 1 (G1) and those without SRD in G2. The primary endpoint was the mean change in BCVA between baseline and month 12 (M12). Secondary endpoints were the mean change in central retinal thickness (CRT) between baseline and M12, injection number, and proportion of patients who gained/lost ≥15 letters.
Seventy-eight eyes were included, 39 in each group. Baseline BCVA was similar in both groups (45.2 and 45.3 letters). Mean change in BCVA between baseline and M12 was not statistically different: 11 ± 12 letters in G1 and 12 ± 13 letters in G2 (P = 0.78). Baseline CRT was 650 ± 130 μm in G1 and 480 ± 79 μm in G2. Mean change in CRT was -235 ± 170 μm in G1 and -130 ± 96 μm in G2 (P = 0.013). Patients received 5.2 and 5.5 injections in G1 and G2 (P = 0.46). In group 1, 38.5% and 2.6% of patients respectively gained and lost ≥15 letters versus 41% (P = 0.1) and 5.1% (P = 0.1) in G2.
Similar BCVA gains were observed regardless of the presence of SRD. The higher visual gain usually observed in DME with SRD could be associated with a lower baseline BCVA.
评估浆液性视网膜脱离(SRD)对雷珠单抗治疗的糖尿病性黄斑水肿(DME)患者功能和解剖学结局的影响。
本回顾性研究纳入了所有连续接受雷珠单抗治疗且患有SRD的患者。对于每例患有SRD的患者,随机纳入一名基线最佳矫正视力(BCVA)相同但无SRD的患者,以对其基线BCVA进行调整。所有患有SRD的患者纳入第1组(G1),无SRD的患者纳入第2组(G2)。主要终点是基线至第12个月(M12)时BCVA的平均变化。次要终点是基线至M12时中心视网膜厚度(CRT)的平均变化、注射次数以及视力提高/降低≥15字母的患者比例。
共纳入78只眼,每组39只。两组的基线BCVA相似(分别为45.2和45.3字母)。基线至M12时BCVA的平均变化无统计学差异:G1组为11±12字母,G2组为12±13字母(P = 0.78)。G1组的基线CRT为650±130μm,G2组为480±79μm。G1组CRT的平均变化为-235±170μm,G2组为-130±96μm(P = 0.013)。G1组和G2组患者分别接受了5.2次和5.5次注射(P = 0.46)。在第1组中,38.5%和2.6%的患者视力分别提高和降低≥15字母,而在G2组中这一比例分别为41%(P = 0.1)和5.1%(P = 0.1)。
无论是否存在SRD,观察到的BCVA改善相似。通常在伴有SRD的DME中观察到的更高视力改善可能与更低的基线BCVA有关。