2024-516970-31-00招募中2 期
Molecular imaging exploration of ocular angiogenic activity and evaluation of its value in therapeutic follow-up of AMD patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The PET signal intensity ratios (SUVmax) of the AMD and contralateral eyes at M0 and M4 will be compared by a paired means comparison test.
研究概览
简要总结
Evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in 20 patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the induction phase (after 3 months of treatment).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •signed informed consent
- •Patient with unilateral AMD, with at least 1 focus of choroidal neovascularization on OCT, naïve to any antiangiogenic treatment.
- •Initial check-up including at least OCT and visual acuity measurement, maximum 1 month old at the time of the 68Ga-NODAGA-RGD PET scan
- •affiliation to a social security scheme.
排除标准
- •pregnant or breast-feeding women
- •Age ≤ 18 years
- •Patients with bilateral AMD
- •Patients with AMD with no neovascularization focus as assessed by the standard diagnostic battery
- •Patients previously treated with antiangiogenic therapy.
- •Patients suffering from any other ophthalmological pathology
- •Monophtalmic patients
结局指标
主要结局
The PET signal intensity ratios (SUVmax) of the AMD and contralateral eyes at M0 and M4 will be compared by a paired means comparison test.
The PET signal intensity ratios (SUVmax) of the AMD and contralateral eyes at M0 and M4 will be compared by a paired means comparison test.
次要结局
- The relationships between PET signal intensity (SUVmax) and retinal thickness measured by OCT, for each eye, will be documented at M0 and M4 respectively by a correlation study.
- The links between PET signal intensity (SUVmax) and the visual acuity score measured with each of the psychometric scales (ETDRS and Parinaud), for each eye, will be documented at M0 and M4 respectively by a correlation study.
研究者
Philippe GARRIGUE
Scientific
Centre Hospitalier Regional De Marseille
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Molecular Imaging Exploration of Ocular Angiogenic Activity and Evaluation of Its Interest in the Therapeutic Follow-up of Patients With AMD (Age-related Macular Degeneration)Age Related Macular DegenerationNCT04005443Assistance Publique Hopitaux De Marseille20
进行中（未招募）
1 期
Molecular imaging exploration of ocular angiogenic activity and evaluation of its relevance in the therapeutic follow-up of AMD patients.MedDRA version: 20.0Level: PTClassification code 10025409Term: Macular degenerationSystem Organ Class: 10015919 - Eye disordersAge-related macular degenerationEUCTR2019-000946-37-FRAssistance Publique-Hôpitaux de Marseille20
招募中
2 期
Ga-68-DOTA-(RGD)2 PET/CT: imaging angiogenesis in patients with low-flow vascular malformationslow-flow vascular malformationlymphatic malformationvenous malformation10007510NL-OMON44225Radiologie en Nucleaire Geneeskunde20
已完成
2 期
Ga-68-DOTA-(RGD)2 PET/CT: imaging angiogenesis in patients with arterio-venous malformationsarterio-venous malformation10005330AVMNL-OMON53156Radiologie en Nucleaire Geneeskunde10
尚未招募
不适用
Wide Field OCTA in Ocular DiseasesDiabetic RetinopathyUveitisRetinal Vein OcclusionMyopiaBest DiseaseNCT07298174IRCCS San Raffaele200