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

Luye Pharma Group

Status and phase: Not yet enrolling; Phase 3

Conditions: Age Related Macular Degeneration

Treatments: Drug: LY09004; Drug: Eylea

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04572698

LY09004/CT-CHN-302

Details and patient eligibility

About

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)

Full 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.

Enrollment: 416 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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416 participants in 2 patient groups

LY09004

Experimental group

Description:

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

Treatment:

Drug: LY09004

EYLEA

Active Comparator group

Description:

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

Treatment:

Drug: Eylea