Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia Without Neovascularization (MACTEL 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Effect of intravitreal ranibizumab treatment on visual acuity
研究概览
简要总结
This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss in people with macular telangiectasia, a condition in which new blood vessels grow in the retina at the back of the eye and can leak. Such changes in blood vessels are seen in other diseases associated with changes in a body chemical called vascular endothelial growth factor (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease, age-related macular degeneration, with similar changes in eye blood vessels.
People 18 years of age and older with macular telangiectasia in both eyes with no new blood vessel growth in either eye may be eligible for this study. They must have vision better than 20/400 in the study eye.
Participants undergo the following procedures:
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Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on the response to treatment and the side effects, additional injections may be given every 4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection to prevent infection.
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Evaluations before starting treatment, at the time of each injection, and 8 weeks after the last treatment:
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History and physical examination.
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Eye examination with dilation, microperimetry and photography: The eye examination measures visual acuity, eye pressure and eye movements. For the microperimetry test, subjects sit in front of a computer screen and press a button when they see a light on the screen. Measurements and photographs of the retina are also taken.
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Fluorescein and indocyanine green angiography to examine the blood vessels in the eye: A dye called fluorescein or indocyanine green is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels.
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Pregnancy test: Women who are able to become pregnant have a urine pregnancy test before each ranibizumab injection.
详细描述
Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula. This is the group 2 in the Gass classification of idiopathic juxtafoveal telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These patients typically are diagnosed in their fifth or sixth decade of life. Both sexes may be affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle venules characterize this disorder. The pathogenesis of the disease is unknown. Because of the leakage of the retinal vessels and also the finding of neovascularization, it is possible that vascular endothelial growth factor (VEGF) may be implicated in this disease.
The purpose of this study is to evaluate the possible role of ranibizumab for the treatment of eight participants with macular telangiectasia with hyperfluorescence on fluorescein angiography, with vision better than 20/400, without neovascularization. The primary outcome of this study will be the proportion of participants that lose 15 letters or more in ETDRS BCVA at 12 months compared with baseline. The secondary outcomes measured at one year will include the proportion of participants who lose 10 letters or more, the mean change in ETDRS BCVA, the change in central retinal thickness, the extent of fluorescein leakage, the change in fundus autofluorescence, change in size of neovascular membrane and the change in central retinal sensitivity. This is a pilot study designed to evaluate the feasibility and potential efficacy of treating patients with macular telangiectasia in a larger, phase III study within the organization of the MAC TEL Research Group, sponsored by the Lowy Foundation. Currently, the research group is enrolling 200 patients affected with this condition for a natural history study in 22 international clinical centers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Effect of intravitreal ranibizumab treatment on visual acuity
次要结局
- ETDRS BCVA, area of retinal leakage, retinal thickness, area of hypofluoresence, central retinal sensitivity