A Study to Compare LY09004 and Eylea in the Treatment of Wet Age-related Macular Degeneration（wAMD）

NCT04572698 | Unknown Phase 3

• 1 other identifier: LY09004/CT-CHN-302
• Study Type: interventional
• Target: 416
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Age Related Macular Degeneration

Keywords

w-AMD; LY09004; EYLEA; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• BCVA（best corrected visual acuity ）

  Assess the BCVA change similarity from baseline of LY09004 and EYLEA

  week 24

Secondary Outcomes (4)

• 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

• Letter

  week 24, week 52

• Central television omentum thickness

  week 24, week 52

• CNV(Choroidal neovascularization) leakage area

  week 24, week 52

Other Outcomes (1)

• AE(adverse event)

  week 52

Study Arms (2)

LY09004

EXPERIMENTAL

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

Drug: LY09004

EYLEA

ACTIVE COMPARATOR

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

Drug: Eylea

Interventions

LY09004 DRUG

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

Also known as: Recombinant Human Vascular Endothelial Growth Factor Receptor Antibody Fusion Protein Eye Injection

LY09004

Eylea DRUG

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

EYLEA

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Use of intraocular or systemic corticosteroids within 3 months before screening, or use of periocular corticosteroids within 1 month;
• Any active intraocular or periocular infection (for example: blepharitis, infectious conjunctivitis, keratitis) in either eye;
• Any history of glaucoma;
• Any evidence of pseudocapsular exfoliation syndrome in either eye;
• A history of vitreous hemorrhage within 3 months before screening in either eye;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead
• Shan Dong Boan Biotechnology Co., Ltd(Co-sponsor): collaborator

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Youxin Chen

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youxin Chen

CONTACT

8613801025972; chenyouxinpumch@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 1, 2020
• Study Start: November 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share