Multicentre study to evaluate safety and efficacy of HL217 topical ophthalmologic solution in the treatment of exudative Age-Related Macular Degeneratio
- Conditions
- AMD (age-related macular degeneration)MedDRA version: 20.0Level: LLTClassification code 10068530Term: Macular degeneration progressionSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-000642-35-BG
- Lead Sponsor
- HANLIM PHARM CO., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
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 if available with 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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
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 with either major atrophy and no possible vision recovery, or ocsecondary 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 characteristic 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) > 25 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;
15. Ongoing ocular infection or inflammation in either eye, suspected ocular infection and active or suspected periocular infection;
16. A history of cataract surgery complicated by vitreous loss in the study eye;
17. Congenital eye malformations in the study eye;
18. A history of penetrating ocular trauma in the study eye;
19. Any history of clinically significant vascular disease, and any personal or family history of long QT syndrome, or evidence of abnormalities in cardiac conduction or electrolyte disturbance;
20. Patient with high thromboembolic risk
21. Hypersensitivity to the active substance aflibercept or to any of the excipients;
22. Patient under administrative or legal supervision;
23. Females of childbearing potential (i.e., who are not postmenopausal for at least 1 year or surgically sterile like hysterectomy, bilateral salpingectomy and bilateral oophorectomy 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;
24. Participation in any other investigational device or drug clinical research study within 30 days of Visit 1 - Screening/Randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method