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临床试验/NCT07009574
NCT07009574尚未招募不适用

Factors Associated to Treatment Burden in Patients Affected by Myopic Choroidal Neovascularization

Policlinico Gaspare Rodolico - San Marco Catania1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To assess treatment burden

研究概览

简要总结

Pathologic myopia (PM) is characterized by progressive eye elongation associated with degenerative changes in the retinal and choroidal tissue. Myopic choroidal neovascularization (mCNV) is a well-known complication of PM, occurring in 5-11% of cases and representing a main cause of visual impairment in working people under the age of 50.

The management of patients affected by active mCNV have been revolutionized by the advent of intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs.

Patients affected by mCNV needs intravitreal injections and visits to assess the need of retreatment with assiduity. It represents a significant burden for patients, caregivers as well as medical equipe.

The aim of this study is to investigate the factors associated with the number of anti-VEGF injections and hospital visits necessary to get mCNV disease stabilization and to identify predictive factors of treatment burden.

详细描述

Patients affected by treatment-naive mCNV will be included in a 12-month monocentric retrospective cohort study; all patients have been treated with intravitreal anti-VEGF injections between 2020 and 2024 in the Eye Clinic Policlinico Gaspare Rodolico, (Catania, Italy). The study adheres to the tenets of the Helsinki Declaration and ita has been approved by the Institutional review board of the University of Catania (Catania 1 Local Ethical Committee). Informed consent was given by patients at the start of the treatment.

Before starting the treatment, all patients have received a complete ophthalmic examination including a best-corrected visual acuity (BCVA) test, biomicroscopic slit-lamp examination, fundus examination in mydriasis, OCT and OCTA. All patients underwent one intravitreal injection at baseline (0.5 mg ranibizumab or 2.0 mg aflibercept); additional intravitreal injections were administered over the follow-up period according to the activity signs detected (pro-re-nata treatment protocol). Any signs of activity were detected by OCT and OCTA and fluorescein angiography has been performed whenever deemed necessary. Myopic active CNV was defined by clinical (retinal haemorrage detection on fundus examination) and OCT signs (intraretinal cysts, subretinal fluid and subretinal hyperreflective exudation with fuzzy borders). Fluorescein Angiography (FA) was performed .

Clinical and imaging data of the baseline examination and of the 12-month visit (M12) after the first intravitreal injection will be collected.

Best-corrected visual acuity was tested on standard Early Treatment Diabetic Retinopathy Study (ETDRS) charts converted into logarithmic scale of the minimal angle of resolution (logMAR). OCT and FA were carried out by Spectralis HRA+OCT with a confocal scanning laser ophthalmoscope (Heidelberg Engineering, Heidelberg, Germany). The OCT scan protocol used was a 15°x15° 67-section macular cube with additional high resolution horizontal and vertical single lines centred on the CNV. AngioVue XR Avanti (Optovue Inc, Fremont, California, USA) was employed to perform OCTA. A light source of 840 nm was used and the A-scan rate was 70,000 per second with a bandwidth of 50 nm. The macula images (6mmx6mm) obtained by OCTA were centered on the foveola. Each volume contained 400x400 A-scans with two consecutive B-scans acquired in each fixed position. The split-spectrum amplitude-decorrelation angiography (SSADA) method was used to capture the dynamic motion of red blood cells. mCNV areas were selected manually using AngioAnalytics software on the outer retina slab.

The values of the "CNV select area" will be included in the analysis as mCNV size. The Central Macular Thickness (CMT, micron) automatically provided by the machine, will be collected.

研究设计

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

入排标准

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

入选标准

  • axial length>26 mm or refractive error (spherical equivalent) <-6 Diopters
  • clinical changes typical of Pathologic myopia
  • diagnosis of subfoveal or juxtafoveal treatment-naïve myopic choroidal neovascularization (mCNV)
  • only one eye per patient was included in the analysis, in cases of patients treated bilaterally only the first eye treated was included

排除标准

  • Extrafoveal mCNV location
  • Other retinal diseases
  • any inflammatory condition which may cause CNV including multifocal choroiditis, puntate inner choroidopathy and white dot syndrome
  • previous ocular surgery (except for cataract extraction performed before the baseline visit)
  • inferior quality imaging

研究组 & 干预措施

Patients affected by myopic choroidal neovascularization

干预措施: anti-VEGF intravitreal treatment in patients affected by myopic choroidal neovascularization (Drug)

结局指标

主要结局

To assess treatment burden

时间窗: one year

The number of access of the patient to the hospital for any clinical need (intravitreal injections administration, imaging examinations and visits) in the first year of anti-VEGF treatment.

次要结局

  • Visual Acuity(one year)
  • Intraretinal Cysts(one year)
  • Subretinal fuzzy material(one year)
  • Subretinal fluid(one year)
  • Subretinal fibrosis(one year)
  • Cnv maturity pattern(one year)

研究者

发起方
Policlinico Gaspare Rodolico - San Marco Catania
申办方类型
Other
责任方
Principal Investigator
主要研究者

Niccolò Castellino

Assistant Professor of Ophthalmology

Policlinico Gaspare Rodolico - San Marco Catania

研究点 (1)

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