To Compare the Efficacy and Safety of Recombinant Human Vascular Endothelial Growth Factor Receptor Antibody Fusion Protein Eye Injection（LY09004） and Eylea in the Treatment of Wet Age-related Macular Degeneration（wAMD）: a Randomized, Double-blind, Parallel Controlled, Multicenter Clinical Trial

Luye Pharma Group Ltd.0 sites416 target enrollmentNovember 2020

ConditionsAge Related Macular Degeneration

InterventionsLY09004 Eylea

DrugsLY09004 Eylea

Overview

Phase: Phase 3
Intervention: LY09004
Conditions: Age Related Macular Degeneration
Sponsor: Luye Pharma Group Ltd.
Enrollment: 416
Primary Endpoint: BCVA（best corrected visual acuity ）
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A randomized, double-blind, parallel controlled, multicenter clinical trial to compare the efficacy and safety of LY09004 and EYLEA in the Treatment of Wet Age-related Macular Degeneration（wAMD)

Detailed Description

This is a randomized, double-blind, parallel controlled, multicenter clinical trial. The primary objective is to assess the efficacy similarity of LY09004 and EYLEA in the treatment of w-AMD. The secondary objective is to assess the safety similarity of LY09004 and EYLEA in the treatment of w-AMD.

Registry

clinicaltrials.gov

Start Date

November 2020

End Date

December 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luye Pharma Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient or their legal representatives must give the written informed consent form voluntarily;
•Aged ≥ 50 years, male or female;
•Patients confirmed diagnosis of w-AMD, currently have active lesions, which are defined any of the following in the macular area: ① intraretinal fluid; ② intraretinal lipid exudation; ③ subretinal fluid; ④ subretinal hemorrhage; ⑤ retinal pigment epithelium detachment;
•The total area of all types of lesions in the study eye ≤ 30mm2 (the area of 12 optic discs);
•The BCVA between 73-24 letters (including boundary values) in the study eye is inclusive using the ETDRS, which is equivalent to 20/40 to 20/320 of Snellen；
•Non-study eye use ETDRS testing to detect BCVA ≥19 letters，which is equivalent to 20/400 of Snellen;
•At hte time of screening, childbearing-age (such as women who have not undergone surgical sterilization or have been postmenopausal less than one year) have a negative blood pregnancy test result. Childbearing-age male and female agree to take effective contraceptive measures throughout the study period and for at least 3 months after medication.

Exclusion Criteria

•Any opacity of refractive media or non-dilated pupils in the study eye interference with visual acuity detection and the evaluation of anterior segment and fundus;
•Study eye retinal hemorrhage ≥ 4 optic disc area;
•Central fovea of the study eye affected by geographic atrophy, scars or fibrosis, dense subfoveal exudation, and macula center affected by retinal pigment epithelium (RPE) tear;
•Any concurrent conditions in the study eye that affects central vision (such as diabetic retinopathy, retinal vein occlusion, uveitis, vascular streaks, pathological myopia, retinal detachment, macular hole, epimacular membrane, toxoplasmosis , Optic nerve disease, polypoid choroidal vascular disease (PCV), etc.);
•Any history of the following ophthalmic surgery in the study eye: vitrectomy, anti-glaucoma surgery, macular transposition;
•Any evidence of external eye surgery within 1 month or cataract surgery within 3 months before screening in the study eye;
•Any the following treatment in the study eye within 3 months before screening: Verteporfin photodynamic therapy (PDT), macular laser photocoagulation, transpupillary thermotherapy (TTT), and other operations for the treatment of AMD;
•Aphakia (excluding intraocular lens) or posterior lens capsule rupture (except for YAG laser posterior capsulotomy after intraocular lens implantation more than 1 month from screening) in the study;
•Afferent pupil defect (APD) in the study eye;
•Patients have received anti-VEGF(vascular endothelial growth factor ) treatment within 6 months before screening, such as ranibizumab, bevacizumab, conbercept, etc in any eye or the whole body;

Arms & Interventions

LY09004

LY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.

Intervention: LY09004

EYLEA

EYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.

Intervention: Eylea

Outcomes

Primary Outcomes

BCVA（best corrected visual acuity ）

Time Frame: week 24

Assess the BCVA change similarity from baseline of LY09004 and EYLEA

Secondary Outcomes

CNV(Choroidal neovascularization) leakage area(week 24, week 52)
Letter(week 24, week 52)
BCVA(week 4, week 8, week 12, week 16, week 20, week 28, week 32, week 36, week 40, week 44, week 48, week 52)
Central television omentum thickness(week 24, week 52)