Vision improvement in retinal degeneration patients by implantation of retina together with retinal pigment epithelium
Vision improvement in retinal degeneration patients by implantation of retina together with retinal pigment epithelium
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DOI：
10.1016/j.ajo.2008.04.009
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发表时间：
2008-08-01
影响因子：
4.2
通讯作者：
Seiler, Magdalene J.
中科院分区：
文献类型：
--
作者：
Radtke, Norman D.;Aramant, Robert B.;Seiler, Magdalene J.
目得：目的：研究视网膜色素变性（RP）和干性年龄相关性黄斑变性（AMD）患者手术眼视力为20/200或更差时，植入神经视网膜祖细胞层（片）及其视网膜色素上皮（RPE）的有效性和安全性。10名患者（6名RP，4名AMD）的一只眼睛接受了视网膜植入，并在临床实践环境中进行了II期试验。早期治疗糖尿病视网膜病变研究（EDTRS）是首要的玛丽结局指标。所有植入受体和9个10个组织donors. RESULTS组织类型：7例患者（3 RP，4 AMD）表现出改善EDTRS视力（VA）评分。其中3例患者（1例RP，2例AMD）的双眼均显示相同程度的改善。1例RP患者视力保持不变，2例RP患者视力下降。1例RP患者的视力从20/800提高到20/200 ETDRS超过5年;在6年的检查中，它仍然保持在20/320，而非手术眼已经恶化为手部运动视力。与第2年的微视野检查结果相比，该患者第5年的光敏感度增加了22.72%;其他患者的敏感度没有改善。虽然没有发现供体和受体之间的匹配，没有排斥的植入组织观察clinically.CONCLUSIONS：7（70%）的10例患者表现出改善VA。这一结果为视网膜植入物的安全性和有益效果提供了临床证据，并证实了视网膜变性动物模型的结果。
PURPOSE: To demonstrate efficacy and safety of the implantation of neural retinal progenitor cell layers (sheets) with its retinal pigment epithelium (RPE) in retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD) patients with 20/200 or worse vision in the surgery eye.DESIGN: Interventional nonrandomized clinical trial.METHODS: Ten patients (six RP, four AMD) received retinal implants in one eye and were followed in a phase II trial conducted in a clinical practice setting. Early Treatment Diabetic Retinopathy Study (EDTRS) was the prig mary outcome measure. All implant recipients and nine of 10 tissue donors were deoxyribonucleic acids typed.RESULTS: Seven patients (three RP, four AMD) showed improved EDTRS visual acuity (VA) scores. Three of these patients (one RP, two AMD) showed improvement in both eyes to the same extent. Vision in one RP patient remained the same, while vision in two RP patients de, creased. One RP patient has maintained an improvement in vision from 20/800 to 20/200 ETDRS for more than five years; at the six-year examination, it was still maintained at 20/320 while the nonsurgery eye had deteriorated to hand motion vision. This patient also showed a 22.72% increase in light sensitivity at five years compared to microperimetry results at two years; the other patients showed no improved sensitivity. Although no match was found between donors and recipients, no rejection of the implanted tissue was observed clinically.CONCLUSIONS: Seven (70%) of 10 patients showed improved VA. This outcome provides clinical evidence of the safety and beneficial effect of retinal implants and corroborates results in animal models of retinal degeneration.