Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
研究概览
简要总结
Background: To identify characteristic morphological changes of the retina, their change over time and the association with visual function after combined photodynamic therapy (PDT) and intravitreal triamcinolone (IVTA).
Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes within intra- and subretinal compartments and their detailed analysis and grading.
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
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cnv secondary to age related macular degeneration
排除标准
- •glaucoma, diabetic retinopathy
结局指标
主要结局
visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
时间窗: Day 1, week 1, 4 and 12
"Reduced fluence versus standard photodynamic therapy in combination with intravitreal triamcinolone: short-term results of a randomised study" Baseline characteristics were well balanced in both groups (p\>0.05). At week 12, patients in group A had a mean loss of -3.7 letters compared with a gain of 3.4 letters in group B (p = 0.04, between both groups). Both treatment groups showed a similar course regarding CRT as well as MS (p\>0.05). In 70% (14/20) of group A and 15% (3/20) of group B, a choroidal hypoperfusion in the area of treatment was observed after treatment (p\<0.001). In 70% of group A and 55% of group B, a repeat treatment was indicated at week 12 (p = 0.55). At month 3, the rPDT+IVTA group showed a significantly better visual outcome, less alteration of the choroid and a trend for lower recurrence rate than the sPDT+IVTA group. Further follow-up of this study will provide information on long-term functional results and treatment durability.
次要结局
未报告次要终点