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临床试验/NCT00805649
NCT00805649已完成4 期

Combined Therapy in ARMD - Retrospective Case Series

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Best corrected visual acuity

研究概览

简要总结

The purpose of this study is to investigate the efficacy of combined intravitreal therapy with or without prior photodynamic therapy in patients with wet age-related macular degeneration (AMD).

In patients with wet AMD, a significant improvement in vision was observed after combined intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the long-term sustainability of the therapeutic benefits.

详细描述

This prospective study of a case series included eyes with predominantly classic lesions (Group 1; n = 52) and eyes with occult lesions (Group 2; n = 106). Patients with predominantly classic lesions received low fluorescence photodynamic therapy (42 J/cm2 for 72 sec), followed by, 24 hours later, a 1.5 mL core pars plana vitrectomy with intravitreal injection of dexamethasone (0.8 mg) and bevacizumab (1.25 mg). Patients with occult lesions received a 0.4 mL core pars plana vitrectomy with intravitreal injection of triamcinolone (8 mg) and bevacizumab (1.25 mg). At baseline and follow-up examinations, the best-corrected visual acuity (BCVA; logMar), central macular thickness (optical coherence tomography), intraocular pressure (IOP; Goldmann tonometry) were determined. In addition, the need for retreatment was assessed, and adverse events were monitored.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Wet age related macular degeneration

排除标准

  • Opacities in lens or cornea
  • Ongoing intraocular inflammation

研究组 & 干预措施

1

Experimental

eyes with predominately classic lesions

干预措施: Low fluorescence Photodynamic therapy (Procedure)

1

Experimental

eyes with predominately classic lesions

干预措施: core pars plana vitrectomy (Procedure)

1

Experimental

eyes with predominately classic lesions

干预措施: dexamethasone (Drug)

1

Experimental

eyes with predominately classic lesions

干预措施: bevacizumab (Drug)

2

Experimental

eyes with occult lesions

干预措施: bevacizumab (Drug)

2

Experimental

eyes with occult lesions

干预措施: core pars plana vitrectomy (Procedure)

2

Experimental

eyes with occult lesions

干预措施: triamcincolone (Drug)

结局指标

主要结局

Best corrected visual acuity

时间窗: at the day of exam

Central macular thickness

时间窗: at the day of exam

次要结局

未报告次要终点

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Koss

PI

Johann Wolfgang Goethe University Hospital

研究点 (1)

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