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Age Related Macular DegenerationPhase 3NCT04572698

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

A Phase 3 study testing LY09004 and Eylea in people with Age Related Macular Degeneration, run by Luye Pharma Group Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
LY09004 and Eylea
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
No sites listed yet
Study dates
Nov 2020to Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • 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.;
  • History of allergy to the therapeutic or diagnostic drugs used in the research protocol, including allergies to the test articles;
  • Diabetic subjects with diabetic retinopathy or glycosylated hemoglobin> 9%;
  • Any history of surgery within 1 month before screening, and/or any currently unhealed wounds, ulcers, fractures, etc.;
  • Any infectious disease requiring systemic treatment (oral, intramuscular or intravenous) during screening;
  • 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;
  • 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;
  • Subjects with systemic immune diseases;
  • Poorly-controlled blood pressure (defined as: after receiving antihypertensive drugs, the subject's systolic value ≥160 mmHg or diastolic value ≥100 mmHg at seat);
  • Any uncontrollable clinical disease (such as serious mental, respiratory and other system diseases and malignant tumors);
  • 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);
  • 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);
  • 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;
  • Positive Hepatitis C virus (HCV) antibody, Treponema pallidum antibody, and human immunodeficiency virus (HIV) antibody;
  • Nursing (lactating) women;
  • Participation in clinical trials of any drug (excluding vitamins and minerals) within 3 months before screening;
  • Others need to be excluded according to the judgement of the investigator.

Trial locations and contacts

No sites are listed yet.

Youxin Chen contact

8613801025972

chenyouxinpumch@163.com

About this study

Official title: 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)

Read the 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.

Being tested
LY09004, Eylea
Keywords
w-AMD, LY09004, EYLEA, efficacy, safety
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY09004Drug

    Also called Recombinant Human Vascular Endothelial Growth Factor Receptor Antibody Fusion Protein Eye Injection

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

  • EyleaDrug

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

Study groups in NCT04572698
Study groupRoleWhat they receive
LY09004ExperimentalLY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.
Receives: Drug: LY09004
EYLEAActive comparatorEYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.
Receives: Drug: Eylea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BCVA（best corrected visual acuity ）

    Assess the BCVA change similarity from baseline of LY09004 and EYLEA

    Measured: week 24

Secondary outcomes (4)

  1. BCVA

    Assess the BCVA change similarity from baseline of LY09004 and EYLEA

    Measured: week 4, week 8, week 12, week 16, week 20, week 28, week 32, week 36, week 40, week 44, week 48, week 52

  2. Letter

    Proportion of subjects with 5 / 10 / 15 letters more than baseline in study eye

    Measured: week 24, week 52

  3. Central television omentum thickness

    Changes of central television omentum thickness from baseline in study eyes

    Measured: week 24, week 52

  4. CNV(Choroidal neovascularization) leakage area

    Changes of CNV leakage area of study eye compared with baseline

    Measured: week 24, week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study startNov 2020 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
416 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04572698
Sponsor's protocol ID
LY09004/CT-CHN-302
Status last verified
Sep 2020
First submitted
21 Sep 2020
Last updated
1 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY09004 and Eylea in people with Age Related Macular Degeneration, run by Luye Pharma Group Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Youxin Chen (8613801025972, chenyouxinpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BCVA（best corrected visual acuity ） (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04572698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.

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