Abstract
Purpose: :
To evaluate fixation stability and macular sensitivity in patients with retinitis pigmentosa (RP), before and 30 days after single intravitreal injection of autologous bone marrow stem cells (ABMSC).
Methods: :
A prospective, phase II, nonrandomized trial, including 20 patients with RP. Fixation stability was assessed calculating the bivariate contour ellipse area (BCEA) for fixations recorded during microperimetric (36 test poins / 10 degrees visual field radios from fixation point; MAIA - CenterVue - Italy) test, and macular sensitivity was calculated as the average threshold (AVTH) for the tested points. Examinations were performed at baseline and 30 days after intravitreal ABMSC (0.1 ml; ~1000000 cells) into one study eye of each patient.
Results: :
No adverse side effect due to the injection was observed for the 20 patients that finished the first month follow-up. Although on average slightly narrowed, no significant change was observed for BCEA after treatment. Mean ± SE BCEA was 4.2 ± 1.6 degrees at baseline and 2.9 ± 0.9 degrees (P=0.4800; Wilcoxon Signed Rank) 30 days after treatment. There was a small, but statistically significant increase on AVTH in this period. Mean ± SE AVTH was 11.2 ± 1.7 dB at baseline, with an intra-individual difference of 1.2 ± 0.5 dB (P=0.0359) 30 days after treatment. The contralateral eye showed no significant changes in this period.
Conclusions: :
Intravitreal injection of ABMSC in advanced RP was associated with slight improvement on macular sensitivity measured by microperimetry. Further analysis from this trial will investigate this findings at long-term, and if there are correlations between this findings and other retinal functional or morphological changes related to intravitreal ABMSC for RP.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01068561
Keywords: retinal degenerations: hereditary • perimetry • regeneration