Outcome of transplantation of autologous retinal pigment epithelium in age-related macular degeneration: a prospective trial.

To present the outcome of a consecutive series of patients who had foveal choroidal neovascularization (fCNV) in age-related macular degeneration (AMD) and were treated with subretinal surgery combined with simultaneous transplantation of autologous retinal pigment epithelial (RPE) cells. Patients with fCNV who were not eligible for laser or photodynamic therapy were included in the study. They underwent subretinal membrane excision with simultaneous transplantation of autologous RPE cells. Eyes with membrane excision alone served as the control. Tests included best corrected visual acuity for far and near with Early Treatment Diabetic Retinopathy Study (ETDRS) and Jaeger charts, multifocal (mf)ERG, central visual field analysis, optical coherence tomography (OCT), and angiography, before surgery, and 1 month and 3 months after treatment, and at 3-month intervals thereafter. The results of final examinations of 53 eyes are presented. In 39 eyes, RPE transplantation was performed (group 1); 14 eyes had membrane excision alone (group 2). In group 1, visual acuity improved significantly, two or more lines in 21 (53.8%) patients; remained stable in 12 patients (30.8%); and decreased two or more lines in 6 patients (15.4%; P=0.0062). In group 2, the corresponding values were 21.1%, 57.8%, and 21.1% (P=0.5377 NS). Statistical analysis of results in the two groups showed a trend in favor of group 1 (P=0.9714). The difference in reading acuity was significant between the two groups (mean change in group 1: 1.85 +/- 0.42 vs. 0.43 +/- 0.47 in group 2; P=0.0001). mfERG response density changes were significantly different between groups 1 and 2 (P=0.0094). No significant decreases in central visual field defects were detected. OCT showed the postoperative median retinal thickness in the lesion area in group 1 to be higher (242.31 +/- 12.30 microm) than in group 2 (202.07 +/- 10.68 microm), showing a trend (P=0.0682). Patients undergoing fCNV removal with autologous transplantation of RPE reached significantly better reading acuity and higher mfERG-response density than control subjects. The results provide evidence that autologous transplantation of RPE is a beneficial supplement to membrane excision alone in patients with fCNV in AMD and may be regarded as a reasonable treatment option.