Long-term Follow-up of Patients With Retinitis Pigmentosa Receiving Intraocular Ciliary Neurotrophic Factor Implants.
Long-term Follow-up of Patients With Retinitis Pigmentosa Receiving Intraocular Ciliary Neurotrophic Factor Implants.
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DOI：
10.1016/j.ajo.2016.07.013
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发表时间：
2016-10
影响因子：
4.2
通讯作者：
Pennesi, Mark E.
中科院分区：
文献类型：
--
作者：
Birch, David G.;Bennett, Lea D.;Duncan, Jacque L.;Weleber, Richard G.;Pennesi, Mark E.
评估通过眼内包囊细胞植入物递送睫状神经营养因子治疗视网膜色素变性（RP）的长期疗效。
一项多中心、假手术对照研究的长期随访。
在三个睫状神经营养因子（CNTF）研究点的36名患者被随机分配在一只眼中接受高剂量或低剂量植入物，在对侧眼中接受假手术。主要终点（12个月时视野敏感度的变化）此前已有报道。在此我们报告24名患者在24个月时相对于假手术治疗眼的长期视力、视野和光学相干断层扫描（OCT）结果，这些患者要么保留植入物，要么取出植入物。
在42个月内，保留植入物的眼睛相较于基线的视野损失明显大于取出植入物的眼睛或假手术眼。到60个月并持续到96个月时，假手术治疗眼、保留植入物的眼睛和取出植入物的眼睛在视野损失方面相当，视力和OCT黄斑体积也是如此。
短期内，从玻璃体内植入物持续释放的睫状神经营养因子导致总视野敏感度的损失大于假手术治疗眼的自然进展。当取出植入物时，与活性植入物相关的这种额外敏感度损失是可逆的。从长期来看（60 - 96个月），没有证据表明在视力、视野敏感度或OCT测量的视网膜结构方面有疗效。
To evaluate the long-term efficacy of ciliary neurotrophic factor delivered via an intraocular encapsulated cell implant for the treatment of retinitis pigmentosa (RP). Long-term follow up of a multicenter, sham-controlled study. Thirty-six patients at three CNTF4 sites were randomly assigned to receive a high- or low- dose implant in one eye and sham surgery in the fellow eye. The primary endpoint (change in visual field sensitivity at 12 months) has been reported previously. Here we report long-term visual acuity, visual field and optical coherence tomography (OCT) outcomes in 24 patients either retaining or explanting the device at 24 months relative to sham-treated eyes. Eyes retaining the implant showed significantly greater visual field loss from baseline than either explanted eyes or sham eyes through 42 months. By 60 months and continuing through 96 months, visual field loss was comparable among sham-treated eyes, eyes retaining the implant and explanted eyes, as was visual acuity and OCT macular volume. Over the short term, ciliary neurotrophic factor released continuously from an intra-vitreal implant lead to loss of total visual field sensitivity that was greater than the natural progression in the sham-treated eye. This additional loss of sensitivity related to the active implant was reversible when the implant was removed. Over the long term (60 – 96 months), there was no evidence of efficacy for visual acuity, visual field sensitivity or OCT measures of retinal structure.
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