Combined Therapy in ARMD - Retrospective Case Series
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
- 否
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
eyes with predominately classic lesions
干预措施: Low fluorescence Photodynamic therapy (Procedure)
1
eyes with predominately classic lesions
干预措施: core pars plana vitrectomy (Procedure)
1
eyes with predominately classic lesions
干预措施: dexamethasone (Drug)
1
eyes with predominately classic lesions
干预措施: bevacizumab (Drug)
2
eyes with occult lesions
干预措施: bevacizumab (Drug)
2
eyes with occult lesions
干预措施: core pars plana vitrectomy (Procedure)
2
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
Michael Koss
PI
Johann Wolfgang Goethe University Hospital
