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临床试验/NCT06717139
NCT06717139进行中(未招募)不适用

Recurrence and Predictive OCT Biomarkers in Neovascular Age Related Macular Degeneration After Discontinuation of Anti-VEGF Therapy

St. Erik Eye Hospital1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2023年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
220
试验地点
1
主要终点
The association between OCT and OCTA biomarkers and disease recurrence in neovascular AMD

研究概览

简要总结

Age-related macular degeneration (AMD) is the most common cause of severe visual impairment and blindness in elderly patients. The central part of the retina is called the macula and is very important for visual acuity. In wet AMD, blood vessels grow under the macula and leak fluid, which leads to swelling in the macula and vision loss. Patients who develop wet AMD are treated with injections into the eye. Today, the treatment can be stopped when the patient has reached an interval of six months between the injections, without showing any signs of disease activity. However, it is not unusual for the swelling in the macula to return and the injections then must be resumed. Today, it is not known exactly how many patients suffer from active disease recurrence, or at what point of time the recurrence usually happens. Furthermore, it remains unclear which patients are at a higher risk of active disease recurrence.

Optical coherence tomography (OCT) is a simple and quick measurement method, similar to taking a photograph of the inside of the eye, to investigate whether there is swelling or other changes in the macula. With OCT, the retina is measured with infrared light. With OCT angiography (OCT-A), which is done in the same simple way, it is also possible to visualize the diseased blood vessels and other changes in the retina.

Under the retina is the choroid layer of the eye, OCT can also be used to measure the thickness and circulation of the choroid.

No large prospective studies have investigated changes on OCT, changes in the diseased vessels on OCT-A, choroidal thickness and choroidal circulation on OCT, and the risk of recurrence of disease requiring treatment in wet AMD.

The study will be conducted as a prospective study at St. Erik's Eye Hospital, a total of 220 patients with wet AMD, where the treatment interval has been extended to 6 months without signs of disease activity, will be included in the study and followed for 18 months, i.e. up to two years after the last injection. Patients with disease recurrence during the follow-up period will be withdrawn from the study and resume treatment.

The aim of the study is to see if there is a relationship between specific changes on OCT and OCT angiography and later recurrence in wet AMD, to investigate how many patients experience disease recurrence and to find out when the recurrence usually occurs. No previous prospective study has investigated these different parameters.

Increased knowledge of how many patients experience recurrence of wet AMD requiring treatment, as well as a deeper understanding of which patients are at greater risk of recurrence, could have a major impact on the planned follow-up in this population. Furthermore, by improving the conditions for being able to identify recurrences earlier, the risk of irreversible vision loss could also decrease in this patient group.

详细描述

Biomarkers predicting recurrence risk in patients with quiescent neovascular AMD

Background Age-related macular degeneration (AMD) is the leading cause of visual impairment and blindness among older individuals. There are two types of AMD. Dry macular degeneration is the most common type and usually progress slowly over time. Dry AMD can progress to wet (neovascular) macular degeneration, which is characterized by blood vessels that grow under the retina and leak fluid. The wet type is more likely to cause a relatively sudden change in vision resulting in serious vision loss.

The diagnostic procedure in neovascular AMD involves an assessment of the macular edema and other structural changes of the macula with Optical Coherence Tomography (OCT), which is a measurement with infrared light of the different layers of the retina. Previously the standard procedure to diagnose wet AMD was performing an angiography with administration of intravenous fluorescein. Today it is possible to visualize the neovascular vessels in wet AMD with OCT-angiography (OCT-A) which is non-invasive and also considerably faster to perform.

With the introduction of intravitreal anti-VEGF-injections 20 years ago, the visual outcome for AMD patients has improved substantially. After a loading dose of anti-VEGF the patient is generally followed and treated according to a treat-and-extend regimen, until the macula remains dry for a longer interval and treatment may be discontinued.

During the last decade the frequency of anti-VEGF injections has grown exponentially, now causing a considerable economic burden and a great logistic challenge for the ophthalmological community and the health care services. , It is therefore of great interest to investigate the discontinuation of therapy in patients that have shown disease stability over extended periods. A recent prospective study showed that 53% of the patients had recurrent macular edema during the first year after treatment was discontinued. However, only 41% of these patients experienced symptoms of visual loss or metamorphopsia at the time of recurrence. This study also showed that patients with a pigment epithelium detachment (PED) had a 74% recurrence rate compared with 48% in patients without a PED, during the first year after treatment discontinuation. It is of great interest predicting which patients are at higher risk of disease recurrence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with wet AMD previously followed and treated according to a "treat and extend" regimen, reaching intervals of 24-32 weeks without any evidence of disease activity on OCT, and BCVA ≥35 letters (Snellen 20/200) and near vision at least 24 points and age 55 years or older are eligible for study inclusion.

排除标准

  • wet AMD with signs of disease activity (neovascular exudative intraretinal fluid or significant subretinal fluid on OCT, or macular bleeding or exudation on fundus exam). Other coexisting causes for macular edema than AMD (for example central serous chorioretinopathy, retinal vein occlusion or diabetic macular edema).

结局指标

主要结局

The association between OCT and OCTA biomarkers and disease recurrence in neovascular AMD

时间窗: From enrollment to the end of study at 18 months

To investigate the impact of the following OCT-A and OCT biomarkers on the risk of disease recurrence in wet AMD: * Neovascular lesion area, largest lesion diameter, largest vessel diameter, presence of anastomosis and loop patterns and vessel density on OCT-A * CT and CVI on EDI-OCT * The presence of a PED and PED size on OCT

次要结局

未报告次要终点

研究者

发起方
St. Erik Eye Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Kvanta

MD, PhD, professor

St. Erik Eye Hospital

研究点 (1)

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