Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To investigate the safety and tolerability of vitrectomy combined with a single dose of subretinal Ranibizumab (Lucentis - 0.5 mg) in patients with submacular hemorrhage and choroidal neovascular membranes secondary to AMD.
研究概览
简要总结
Visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due to Age-Related Macular Degeneration (AMD) are poor. The Submacular Surgery Trial (SST) showed that no statistically significant improvement in vision resulted from surgical removal of the layer of abnormal blood vessels causing the bleeding. However, placement of a gas bubble into the gel of the eye along with removal of the blood has shown some success. However, this does not treat the underlying condition of the AMD.
Intravitreal injections (into the gel of the eye) of a drug called Lucentis has been shown to be highly effective in the treatment of AMD, yet its penetration through areas of thick blood caused by subretinal hemorrhage is not known.
This study is proposing to treat the AMD causing the subretinal hemorrhage with a vitrectomy (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed by Lucentis placed between the layers of the retina and then with or without a gas bubble.
In order to determine if the the subretinal Lucentis alone is beneficial, 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not.
详细描述
Subjects will be followed for a period of 12 months. Based on photographs and other testing procedures, if it is deemed in the subject's best interest, the subject may receive monthly injections of Lucentis to help treat the AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 50 years
- •Vision 20/200 or worse
- •AMD with submacular hemorrhage
- •Hemorrhage more than 25% of the lesion
- •Fibrosis or scar not more than 25% of the entire lesion
- •Hemorrhage less than 3 months old
- •Vision loss occuring within 3 months
排除标准
- •Pregnancy
- •Participating in any other clinical trial
- •Prior treatment for AMD
- •Other medical conditions causing compromised vision
- •Intraocular eye surgery within the previous 12 months
- •Inability to obtain necessary eye photographs
- •Systemic use of anti-VEGF agents
- •Allergy to fluorescein dye
- •Unable to complete all study visits
- •Glaucoma filtering surgery
- •Use of 2 or more treatments for glaucoma
- •Lack of lens in the eye or absence of a posterior capsule
研究组 & 干预措施
A
Does not receive Gas bubble
干预措施: vitrectomy with subretinal lucentis (Drug)
B
Does receive gas bubble
干预措施: vitrectomy with subretinal lucentis (Drug)
结局指标
主要结局
To investigate the safety and tolerability of vitrectomy combined with a single dose of subretinal Ranibizumab (Lucentis - 0.5 mg) in patients with submacular hemorrhage and choroidal neovascular membranes secondary to AMD.
时间窗: 12 months
次要结局
- Mean change in visual acuity, angiographic area, retinal thickness by optical coherence tomography, mean number of retreatments required by 12 months.(12 months)