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S. Binder, C. I. Falkner-Radler, C. Glittenberg, B. Povaay, W. Drexler, I. Krebs; Autologous Retinal Pigment Epithelium (RPE)-Choroid Sheet Transplantation versus Autologous RPE Cell-Suspension Transplantation in Patients With Age-Related Macular Degeneration (AMD) - Clinical Results. Invest. Ophthalmol. Vis. Sci. 2007;48(13):6027.
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Cell based therapies, like RPE transplantation, offer an alternative treatment in retinal degenerative disease with the potential to restore a more normal retinal anatomy and achieve stable long term results. In this prospective randomised cohort study we evaluate the clinical outcome comparing two different autologous transplantation techniques, RPE-choroid flap versus RPE cell- suspension in patients with AMD.
Patients with neovascular AMD, progressive visual loss and unsuitable for Laser, PDT or intravitreal anti-VEGF treatments resp. "non-responders" were included in this study. Patients were randomly assigned to receive after pp Vitrectomy and CNV removal transplantation of a RPE-choroid sheet + silicone tamponade (Gr 1) or transplantation of a RPE cell- suspension+ gas tamponade (Gr 2). Parameters of interest were: Visual acuity far and near (BCDVA: ETDRS, BCNVA: Radner)), intra- and postoperative complication rates, CNV recurrence rate, FLA and ICG angiography.
Outcome Gr 1 (n-7 RPE Ch-flap): Two patients showed sign. improvement from BCDVA, five patients showed stable vision within one line, one patient showed sign. improvement in BCNVA. Vascularisation of the transplant was visible on indocyanine green (ICG) angiography. No recurrence occurred. Complications: Revision surgery was required in 1 case for mild nasal PVR.2 patients developed epiretinal membranes which were removed combined with silicone oil removal. Outcome Gr 2 (n-7 RPE cell suspension): Two patients showed sign .improvement in BCVA, five patients showed stable vision within one line, one patient showed sign. improvement in BCNVA. No recurrence occurred. Complications: In one patient a preretinal cyst and membrane developed, this patient had received silicone oil instead of gas tamponade.
Kolmogorov Smirnow Test showed normal distribution. 2-tailed T-Test showed no significant difference for BCDVA and BCNVA between both treatment groups. Patients in Gr 1 showed a distinct but not statistically significant difference (p=0.065) between baseline and 12 months BCDVA and BCNVA. Patients in Gr 2 showed a distinct, but not statistically significant difference (p=0.053) between baseline and 9months BCDVA and BCNVA.
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