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)

Phase 1

• Conditions: AMD (age-related macular degeneration); MedDRA version: 20.0Level: LLTClassification code 10068530Term: Macular degeneration progressionSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-000642-35-FR
• Lead Sponsor: HANLIM PHARM CO., LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate efficacy of HL217 after multiple eye drop administrations in patients with exudative AMD by measuring macular thickness from D1 to D84 (3 months). <br>;Secondary Objective: 1. Efficacy : evaluation of HL217 efficacy in each group from D1 to D14, D28, D56 and D84.<br><br>2. Safety : evaluation of safety in each group from D1 to D14, D28, D56 and D84.<br><br>;Primary end point(s): • Change from baseline in OCT at Day 84 (=3 months) with subfoveal central macular thickness (CMT) measured in microns using SD-OCT.;Timepoint(s) of evaluation of this end point: Day 1 and Day 84