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Elizabeth Tegins, Michael Javaheri, Dean Eliott, Leo Kim, Hani Salehi-Had, David Hinton, Elliott Sohn; One Year Clinical Outcomes Of A Randomized Clinical Trial Investigating Pre-operative Adjunctive Bevacizumab For Tractional Retinal Detachment (TRD) Due To Proliferative Diabetic Retinopathy (PDR). Invest. Ophthalmol. Vis. Sci. 2013;54(15):5785.
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Utility of pre-operative bevacizumab for TRD due to PDR remains contested due to the risk of TRD progression versus benefit of attenuation of neovascularization. Preliminary three month post-operative data of this reverse translational, double-masked study has been published. In this study, we detail one-year clinical follow-up of this now completed study.
20 eyes of 19 patients were randomized to receive intravitreal bevacizumab injection or sham injection 3-7 days prior to vitrectomy for TRD repair and definitive PDR treatment in a large urban, public hospital. Best-corrected visual acuity (BCVA), need for additional procedures, and postoperative complications were compared in the two groups at 6 and 12 month post-operative follow-up.
Median BCVA in the control group was 20/400 at baseline, 20/400 at post-op month 3 (POM3), 20/170 at POM6, and 20/250 at POM12. The median BCVA in the treated group was 20/630 at baseline, 20/100 at POM3, 20/400 at POM6, and 20/150 at POM12. Four of seven eyes (57%) randomized to bevacizumab had the same or improved VA at POM12 compared to five of eight eyes (62.5%) in the control group. All retinas were attached at POM12, but 6 eyes had decreased VA compared to baseline. In the treatment arm, 1 patient had persistent cystoid macular edema, 1 had ischemic changes postoperatively, and 1 had a visually significant cataract awaiting surgery. In the control arm, 1 patient had recurrent epiretinal membrane and 2 developed NLP vision despite retinal attachment: one from glaucoma and another from severe ischemia. During 12 month follow-up, 1 eye in each group needed repeat surgery for recurrent retinal detachment. No eye required enucleation.
Most eyes in this study experienced at least stable VA at one year follow-up. Need for additional surgical procedures for recurrent detachment is uncommon. However, a relatively high risk of poor visual outcomes despite pre-operative bevacizumab still exist in severe TRD due to end-stage PDR.
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