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

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Drug: LY09004; Drug: Eylea

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.

• Study Type: Interventional
• Enrollment (Anticipated): 416
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Youxin Chen; Phone Number: 8613801025972; Email: chenyouxinpumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient or their legal representatives must give the written informed consent form voluntarily;
2. Aged ≥ 50 years, male or female;
3. 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;
4. The total area of all types of lesions in the study eye ≤ 30mm2 (the area of 12 optic discs);
5. 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；
6. Non-study eye use ETDRS testing to detect BCVA ≥19 letters，which is equivalent to 20/400 of Snellen;
7. 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:

1. 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;
2. Study eye retinal hemorrhage ≥ 4 optic disc area;
3. 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;
4. 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.);
5. Any history of the following ophthalmic surgery in the study eye: vitrectomy, anti-glaucoma surgery, macular transposition;
6. Any evidence of external eye surgery within 1 month or cataract surgery within 3 months before screening in the study eye;
7. 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;
8. 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;
9. Afferent pupil defect (APD) in the study eye;
10. 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;
11. Use of intraocular or systemic corticosteroids within 3 months before screening, or use of periocular corticosteroids within 1 month;
12. Any active intraocular or periocular infection (for example: blepharitis, infectious conjunctivitis, keratitis) in either eye;
13. Any history of glaucoma;
14. Any evidence of pseudocapsular exfoliation syndrome in either eye;
15. A history of vitreous hemorrhage within 3 months before screening in either eye;
16. Any systemic drug (currently in use or may need to use) could cause lens toxicity or retinal toxicity, such as desferrioxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazine, ethambutol, etc.;
17. History of allergy to the therapeutic or diagnostic drugs used in the research protocol, including allergies to the test articles;
18. Diabetic subjects with diabetic retinopathy or glycosylated hemoglobin> 9%;
19. Any history of surgery within 1 month before screening, and/or any currently unhealed wounds, ulcers, fractures, etc.;
20. Any infectious disease requiring systemic treatment (oral, intramuscular or intravenous) during screening;
21. History of a medical condition, including myocardial infarction, unstable angina pectoris, coronary revascularization, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) grade ≥ Grade II cardiac insufficiency, severely unstable ventricular arrhythmia within 6 months before screening;
22. History of diffuse intravascular coagulation and obvious bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before screening, or use of anticoagulant and antiplatelet therapy other than aspirin/NSAIDs within 14 days before screening;
23. Subjects with systemic immune diseases;
24. Poorly-controlled blood pressure (defined as: after receiving antihypertensive drugs, the subject's systolic value ≥160 mmHg or diastolic value ≥100 mmHg at seat);
25. Any uncontrollable clinical disease (such as serious mental, respiratory and other system diseases and malignant tumors);
26. Abnormal liver and kidney function (ALT, AST≥2.5 times the upper limit of normal; total bilirubin≥1.5 times the upper limit of normal; Crea, urea/urea nitrogen≥1.2 times the upper limit of normal);
27. Abnormal blood coagulation function (prothrombin time> upper limit of normal value 3 seconds or activated partial thromboplastin time> upper limit of normal value 10 seconds);
28. Positive Hepatitis B surface antigen (HBsAg), and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test ≥ 1 × 103 copies/mL; Under the condition of positive HBsAg with peripheral blood HBV DNA titer test <1x 103 copies/mL, if the investigator judges that chronic hepatitis B is stable and will not increase the risk of the subject, the subject is eligible for selection;
29. Positive Hepatitis C virus (HCV) antibody, Treponema pallidum antibody, and human immunodeficiency virus (HIV) antibody;
30. Nursing (lactating) women;
31. Participation in clinical trials of any drug (excluding vitamins and minerals) within 3 months before screening;
32. Others need to be excluded according to the judgement of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY09004; LY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.	Drug: LY09004; LY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.; Other Names: Recombinant Human Vascular Endothelial Growth Factor Receptor Antibody Fusion Protein Eye Injection
ACTIVE_COMPARATOR: EYLEA; EYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.	Drug: Eylea; EYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA（best corrected visual acuity ）	Assess the BCVA change similarity from baseline of LY09004 and EYLEA	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA	Assess the BCVA change similarity from baseline of LY09004 and EYLEA	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	Proportion of subjects with 5 / 10 / 15 letters more than baseline in study eye	week 24, week 52
Central television omentum thickness	Changes of central television omentum thickness from baseline in study eyes	week 24, week 52
CNV(Choroidal neovascularization) leakage area	Changes of CNV leakage area of study eye compared with baseline	week 24, week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE(adverse event)	Number of patients with treatment related adverse events assessed by change from baseline.	week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (ACTUAL): October 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: safety; efficacy; EYLEA; w-AMD; LY09004
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Growth Substances; Endothelial Growth Factors
• Other Study ID Numbers: LY09004/CT-CHN-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No