First Author: Z.Rozanova UKRAINE
Co Author(s): N. Umanets M. Alzein 0 0 0 0 0 0 0 0 0
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The purpose of the study is to compare the efficacy of intravitreal ranibizumab injections 0,5 mg (IR) as monotherapy and combination of IR with selective laser coagulation of pigment epithelium (IR+SLCPE) in the treatment of diabetic cystoid macular edema (DCME).
Prospective non-randomized clinical trial. Each subject gave written informed consent to participate in the study.
89 patients (98 eyes) with cystoid abnormalities in the macula by optical coherent tomography (OCT) were undergone visual acuity measurement, biomicroscopy, direct and indirect ophthalmoscopy, macular thickness (MT) measurement on STRATUS OCT 3000, foveal avascular zone (FAZ) measurement on fluorescent angiograms, than were divided into two groups. Group 1: 31 patients (41 eye) mean age 58,5(SD 9,7) years, with diabetes mellitus (DM) type 1−12 patients (38,7%), DM type 2 – 19 patients (61,3%), initial mean MT 506(SD 130) μm, FAZ 1,10(SD 0,24) mm2, visual acuity (VA) 0,24(SD 0,18) were treated by IR 0,5 mg as monotherapy. Group 2: 51 patients (57 eyes) mean age 59,5(SD 9,1) years, with DM type 1 – 20 patients (39,2%), DV type 2 −31 patient (60,8%), initial mean MT 509(SD 120) μm, FAZ 1,13(SD 0,28) mm2, VA 0,24(SD 0,17) were treated by SLCPE one months after IR 0,5 mg. There is no difference in the distribution of patients by severity DCME between two groups − χ2= 5,3, р=0,26. Dynamics of the changes of VA, MT and FAZ were measured during a year after initial IR. Improvement and stabilization of VA regarded as positive treatment result, VA worsening regarded as negative result.
In both groups MT decreased most markedly in 1 months after IR: from 506±20 μm to 264±11 μm (p=0,000) in group 1, and from 509±36 μm to 276±87μm (p=0,000022 by Newman-Keuls test) in group 2, FAZ decreased from 1,1±0,02 mm2 to 0,9±0,24 mm2 (p=0,000) in group 1 and from 1,13±0,04 to 0,94±0,03 mm2 (p=0,00008) in group 2. In accordance with the morphological parameter VA changed in greatest degree 1 month after IR: from 0,24±0,04 to 0,42±0,03 (p=0,000) in group 1 and from 0,24±0,05 to 0,43±0,02 (р=0,00022). Subsequently MT and FAZ slightly enlarged and VA worsened during a year, but all data remained statistically better than at the beginning of the study. Final MT was 376±22 μm, FAZ 1,05±0,03 mm2, VA 0,3±0,04 in group 1, and final MT was 311±12 μm, FAZ 1,04±0,04 mm2, VA 0,33±0,03 in group 2. Only final MT is statistically different between two groups (p=0,03 by Newman-Keuls test). In group 1 VA improved or stabilized on 26 eyes (63,4%), in group 2 on 43 eyes (75,4%). Repeated injections during a year were performed in 92,7% of eyes in group 1, and only in 35,3% of eyes in group 2.
Both methods IR and combination of IR with SLCPE are effective in the treatment of DCME. However combined method is preferable because allows to get a positive result in 75,4%, and reduces the required number of repeated intravitreal injections of ranibizumab during a year.