Dataset Information

Triple therapy: Phaco-vitrectomy with ILM peeling, retinal endophotocoagulation, and intraoperative use of bevacizumab for diffuse diabetic macular edema.

ABSTRACT: The aim of this study was to evaluate the visual acuity and structural outcomes of combined phacovitrectomy with ILM peeling, retinal endophotocoagulation and use of bevacizumab in patients with diffuse diabetic macular edema (DDME).In this prospective, nonrandomized, interventional study we included 29 eyes of 26 patients with DDME. The best-corrected visual acuity (BCVA) and central retinal thickness and volume (CRT and CRV) were recorded at 4, 8, 12, and 16 months after surgery.The mean preoperative BCVA was 0.74±0.36 logMAR (0.3-1.5) and improved finally to 0.4±0.24 logMAR (-0.1-1.0) p=0.000006. The mean preoperative CRT in the 1mm zone was 516±184 microm (256-950) and decreased postoperatively at the last control to 237±75 microm (117-489) p=0.000003. The mean preoperative CRV in the 1mm zone was 0.39±0.14 microL (0.19-0.74) and decreased postoperatively at the last control to 0.17±0.06 microL (0.09-0.36) p=0.000003. The mean preoperative CRT in the 6 mm zone was 407±105 microm (279-640) and decreased postoperatively at the last control to 282±40 µm (212-380) p=0.000004. The mean preoperative CRV in the 6 mm zone was 11.4±2.9 microL (7.85-17.93) and decreased postoperatively at the last control to 7.92±1.0 microL (5.62-10.97) p=0.000003. The 23 (79.3%) eyes showed improvement in BCVA ?0.2 logMAR, 5 (17.2%) eyes improvement or stabilization of BCVA and 1(3.5%) eye deterioration. Preoperative BCVA was a positive factor for prognosis of BCVA at 12th month follow-up (b=0.42; p=0.006), while the negative factors were: previous panretinal photocoagulation (b=-0.24; p=0.04), presence of vitreomacular traction (b=-0.29; p=0.02) and preoperative CRT in the 1000 microm zone (b=-0.24; p=0.07). A greater visual acuity improvement occurred in eyes with worse baseline visual acuity (b=-1.01; p=0.00001). The presentation of vitreomacular traction (b=-0.38; p=0.02), previous panretinal photocoagulation (b=-0.31, p=0.04) and greater preoperative CRT in the 1000 µm zone (b=-0.31; p=0.07) were negative factors for visual improvement.This combined treatment resulted in improvement or stabilization of BCVA and decrease of CRT and CRV. Larger comparative studies are necessary to establish the real impact of this therapeutic approach.

SUBMITTER: Robaszkiewicz J

PROVIDER: S-EPMC3560820 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Triple therapy: Phaco-vitrectomy with ILM peeling, retinal endophotocoagulation, and intraoperative use of bevacizumab for diffuse diabetic macular edema.

Robaszkiewicz Jacek J Chmielewska Katarzyna K Figurska Małgorzata M Wierzbowska Joanna J Stankiewicz Andrzej A

Medical science monitor : international medical journal of experimental and clinical research 20120401 4

<h4>Background</h4>The aim of this study was to evaluate the visual acuity and structural outcomes of combined phacovitrectomy with ILM peeling, retinal endophotocoagulation and use of bevacizumab in patients with diffuse diabetic macular edema (DDME).<h4>Material/methods</h4>In this prospective, nonrandomized, interventional study we included 29 eyes of 26 patients with DDME. The best-corrected visual acuity (BCVA) and central retinal thickness and volume (CRT and CRV) were recorded at 4, 8, 12 ...[more]

PMID: 22460096

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Project description:BackgroundThe relative efficacy and safety of intravitreous aflibercept, bevacizumab, and ranibizumab in the treatment of diabetic macular edema are unknown.MethodsAt 89 clinical sites, we randomly assigned 660 adults (mean age, 61±10 years) with diabetic macular edema involving the macular center to receive intravitreous aflibercept at a dose of 2.0 mg (224 participants), bevacizumab at a dose of 1.25 mg (218 participants), or ranibizumab at a dose of 0.3 mg (218 participants). The study drugs were administered as often as every 4 weeks, according to a protocol-specified algorithm. The primary outcome was the mean change in visual acuity at 1 year.ResultsFrom baseline to 1 year, the mean visual-acuity letter score (range, 0 to 100, with higher scores indicating better visual acuity; a score of 85 is approximately 20/20) improved by 13.3 with aflibercept, by 9.7 with bevacizumab, and by 11.2 with ranibizumab. Although the improvement was greater with aflibercept than with the other two drugs (P<0.001 for aflibercept vs. bevacizumab and P=0.03 for aflibercept vs. ranibizumab), it was not clinically meaningful, because the difference was driven by the eyes with worse visual acuity at baseline (P<0.001 for interaction). When the initial visual-acuity letter score was 78 to 69 (equivalent to approximately 20/32 to 20/40) (51% of participants), the mean improvement was 8.0 with aflibercept, 7.5 with bevacizumab, and 8.3 with ranibizumab (P>0.50 for each pairwise comparison). When the initial letter score was less than 69 (approximately 20/50 or worse), the mean improvement was 18.9 with aflibercept, 11.8 with bevacizumab, and 14.2 with ranibizumab (P<0.001 for aflibercept vs. bevacizumab, P=0.003 for aflibercept vs. ranibizumab, and P=0.21 for ranibizumab vs. bevacizumab). There were no significant differences among the study groups in the rates of serious adverse events (P=0.40), hospitalization (P=0.51), death (P=0.72), or major cardiovascular events (P=0.56).ConclusionsIntravitreous aflibercept, bevacizumab, or ranibizumab improved vision in eyes with center-involved diabetic macular edema, but the relative effect depended on baseline visual acuity. When the initial visual-acuity loss was mild, there were no apparent differences, on average, among study groups. At worse levels of initial visual acuity, aflibercept was more effective at improving vision. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01627249.).

Dataset Information

Triple therapy: Phaco-vitrectomy with ILM peeling, retinal endophotocoagulation, and intraoperative use of bevacizumab for diffuse diabetic macular edema.

Publications

Triple therapy: Phaco-vitrectomy with ILM peeling, retinal endophotocoagulation, and intraoperative use of bevacizumab for diffuse diabetic macular edema.

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