跳至主要内容
临床试验/NCT05716932
NCT05716932已完成不适用

Validity of Focal Laser Photocoagulation Followed by a Single Intravitreal Ranibizumab Injection for Retinal Artery Macroaneurysm.

Dar El Oyoun Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
change in best corrected visual acuity (BCVA)

研究概览

简要总结

Treatment options for Retinal artery Macroaneurysm (RAM) include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]

However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]

.

详细描述

Retinal arterial macroaneurysm (RAM) is an acquired localized arterial dilatation, which often occurs at second or third branches of the central retinal artery. Mostly, elderly hypertensive females above 60 years are affected. One in 4500 people over the age of 40 years is liable to develop a RAM. It may be associated with retinal vein occlusion. [1]

The natural history of a RAM can be divided into a growing phase, followed by gradual fibrosis and/ or thrombosis (closure), and then involution. A growing macroaneurysm may leak, resulting in intraretinal exudation and macular edema. It may rupture producing subretinal, intraretinal, preretinal, and / or vitreous hemorrhage. Approximately 8%-25% of RAMs undergo spontaneous involution without treatment. However, treatment is required for leaking macroaneurysms to prevent macular structural damage. [2,3]

Treatment options for RAM include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]

However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]

.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • We will enroll cases of RAM that had been treated by Direct and perilesional focal laser, followed by a single intravitreal ranibizumab injection a few days later, and had been followed up for at least 6 months

排除标准

  • • RAM treated by a single approach (laser or intravitreal injections),
  • RAM treated by other anti-VEGF injections (not ranibizumab),
  • RAM with a shorter than 6 months of follow-up after combined laser and ranibizumab

结局指标

主要结局

change in best corrected visual acuity (BCVA)

时间窗: 6 months

NCVA change between baseline and final follow up at 6 months

次要结局

  • change in central macular thickness (CMT)((Time frame: 6 months))
  • incidence of complications due to laser or intravitreal injection.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wael Ahmed Ewais

Dr Wael Ewais

Dar El Oyoun Hospital

研究点 (1)

Loading locations...

相似试验

Focal Laser Single Intravitreal Ranibizumab Retinal... | 临床试验