Mechanisms of Retinal Revascularization and Clinical Indicators of Neovascular AMD Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Neovascular changes during nAMD relapse assessed by the use of Optical Coherence Tomography Angiography
研究概览
简要总结
Age-related macular degeneration (AMD) is a chronic and progressive eye disease and is one of the leading causes of vision impairment globally. AMD is referred to as either the dry or the wet type, where the wet type (also called neovascular-AMD or nAMD) is a later stage of the disease with neovascularization and retinal edema being the main attributes. This will usually cause subacute distortion or loss of central vision in patients. Since 2004, a successful treatment alternative for nAMD has been ocular injections with anti-VEGF (anti-Vascular Endothelial Growth Factor), causing the neovascularization and edema to regress and vision to improve. However, injections have to be repeated, usually requiring 8 injections or more during the first year of treatment. This can cause both a risk for serious adverse effects and is a significant financial drain on health care resources.
Patients undergoing treatment are at risk for retinal edema recurrence. The time interval tolerated between injections is individual, and the accepted treatment strategy of today is to gradually, in a stepwise manner, increase the interval between injections. For some patients this extension is well tolerated, but for many patients relapse of proliferations and retinal edema will recur. With state-of-the-art technology OCT-A (optical coherence tomography-angiography) in combination with the clinically, well established examination method of OCT (optical coherence tomography), the project group will study the phenotypic vessel and tissue changes that occur in between injections. Furthermore, the investigators will measure cytokines, chemokines and growth factors in blood samples and the tear film during different treatment stages to see if any single factor is prognostic for poorer response to treatment or relapse.
In the short term, the project group hope that the knowledge gained from this project could lead to a better understanding of the mechanisms behind nAMD neovascular relapse and to apply this to routine screening in the clinics. In the longer term, the project group hope that elucidating the physical mechanisms and molecular changes could enable new targeted therapies to be developed.
Aim 1: To characterize the phenotype of vessels in relapsing nAMD patients and compare to those without relapse using OCT-A imaging Aim 2: To investigate retinal edema and choroidal thickness in correlation with neovascular changes of relapsing nAMD Aim 3: To measure cytokines, chemokines and growth factors in the tear film before and during treatment with anti-VEGF for nAMD
With our main hypothesis being: Relapse of nAMD in patients occurs principally through reconfiguration and vasodilatation of persistent non-regressed vessels following anti-VEGF treatment, while fully regressed vessels remain dormant
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients have to be 18 years or older
- •Newly diagnosed nAMD (group 1) or nAMD treatment for at least 1 year (group 2), both with typical neovascular findings on OCT-A
- •Patients with acceptable travel distance to the hospital
- •Patients accepting to be part of the study
排除标准
- •Other non-AMD macular disorders
- •A spherical equivalent of -6 diopters or less
- •Opacities of the visual axis; Changes of the cornea, anterior chamber, lens or vitreous cavity causing image acquisition artefacts
- •Patients not able to attend extra controls due to age, illnesses or other factors
- •Contraindications of intraocular injection therapy; Active ocular or periocular infection, active and serious intraocular inflammation, hypersensitivity to the drug or recent stroke / heart attack
研究组 & 干预措施
Treatment-naïve
15 patients not previously receiving anti-VEGF treatment for nAMD.
干预措施: Ophthalmic Drugs (Drug)
Undergoing treatment
15 patients already undergoing treatment with anti-VEGF for nAMD.
干预措施: Ophthalmic Drugs (Drug)
结局指标
主要结局
Neovascular changes during nAMD relapse assessed by the use of Optical Coherence Tomography Angiography
时间窗: 12 months after inclusion of patients
Images gathered from OCTA imaging will be collected and vessel phenotype will be compared between different treatment stages to identify how vessels develop over time. The attributes that will be measured are feeder vessel thickness and to assess if new vessels develop "de novo" or by using old vessel pathways. The investigators intend to describe these findings and there are no planned metric measurements. This outcome is considered a descriptive, qualitative outcome.
次要结局
- Choroidal thickness in nAMD patients undergoing treatment with anti-VEGF will be measured by the use of a caliper tool (metric scale) in the Optical Coherence Tomography software(12 months after inclusion of patients)
- Tear film of nAMD patients at different treatment stages to be collected by Schirmers test and further biochemically analysed(12 months after inclusion of patients)
- Blood samples of nAMD patients at different treatment stages will be collected in microtubes and further biochemically analysed(12 months after inclusion of patients)