EUCTR2019-000642-35-FR进行中（未招募）1 期
A phase IIa randomized, double-blind, multicentre study to evaluate safety and efficacy of HL217 topical ophthalmologic solution in the treatment of exudative Age-Related Macular Degeneration (AMD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and menopaused women patients, aged 50 years or more;
- •2. Active subfoveal choroidal neovascularization (CNV) due to Age-related Macular Degeneration (AMD) in the study eye diagnosed using fluorescein and indocyanine green angiography and SD-OCT, total lesion =12 Macular Photocoagulation Study (MPS) disc areas or =30,48 mm², with the active lesion (excluding fibrosis and subretinal hemorrhage) should be =50% of the total lesion size.
- •3. Intraretinal or subretinal fluid due to choroidal neovascularization (CNV) visible on SD-OCT;
- •4. Best-corrected Visual Acuity (BCVA) between 78 and 14 letters, inclusive, in the study eye at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing, with BCVA decrement primarily attributable to neovascular Age-related Macular Degeneration (AMD);
- •5. Treatment naive (i.e., no previous anti-vascular endothelial growth factor [VEGF] treatment in the study eye);
- •6. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus imaging;
- •7. Willing and able to return for all study visits;
- •8. Able to adhere to the study protocol and its requirements;
- •9. Signing a written informed consent prior to selection;
- •10. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •1. Non-study eye best corrected visual acuity (BCVA) worse than 20 letters at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing;
- •2. Choroidal neovascularization (CNV) in the study eye secondary to other causes (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, posterior uveitis, or multifocal choroiditis);
- •3. Polypoidal choroidal vasculopathy (PCV) The diagnosis of PCV required either the presence of elevated orange-red lesions observed at the fundus or the presence of charac- teristic polypoidal vascular lesions by ICGA).
- •4. Previous macular laser photocoagulation or ocular photodynamic therapy in the study eye;
- •5. Media opacities or abnormalities in the study eye that would preclude visualization of the retina;
- •6. Other retinal diseases in the study eye that would interfere with vision; including: retinal pigment epithelial (RPE) tear, subretinal haemorrhage (including the fovea);
- •7. Uncontrolled glaucoma or ocular hypertension in the study eye defined as an Intraocular Pressure (IOP) > 30 millimeters of mercury (mmHg) regardless of concomitant treatment with IOP lowering medications;
- •8. Previous pars plana vitrectomy in the study eye;
- •9. Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrolment;
- •10. Yttrium aluminium garnet (YAG) laser treatment in the study eye within 30 days (1 month) prior to study enrolment;
- •11. Intravitreal/periocular ocular steroids (dexamethasone implant or triamcinolone injection) in the study eye within 90 days (3 months) prior to study enrolment;
- •12. Topical or subconjunctival injection of steroid (except triamcinolone) in the study eye within 15 days;
- •13. Concomitant use of any topical ophthalmic medications in the study eye, including glaucoma medications, unless on a stable dose for at least 90 days (3 months) prior to study enrolment and expected to stay on stable dose throughout study participation. Artificial tears are allowed but not ointments;
- •14. Chronic or recurrent uveitis in the study eye, ongoing ocular infection or inflammation in either eye;
- •15. A history of cataract surgery complicated by vitreous loss in the study eye;
- •16. Congenital eye malformations in the study eye;
- •17. A history of penetrating ocular trauma in the study eye;
- •18. Patient under administrative or legal supervision;
- •19. Females of childbearing potential (i.e., who are not postmenopausal for at least 1 year or surgically sterile for at least 6 weeks prior to Visit 1 - Screening/Randomization) who are lactating, or who are pregnant as determined by a positive urine pregnancy test (UPT) at Visit 1 - Screening/Randomization.
- •20. Participation in any other investigational device or drug clinical research study within 30 days of Visit 1 - Screening/Randomization.
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