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Wet Age-related Macular DegenerationPhase 3NCT07389577

A Study to Compare JL14002 to Lucentis® in Subjects With Wet Age-related Macular Degeneration (wAMD)

A Phase 3 study testing JL14002 monoclonal antibody(Fixed dosing regimen), Ranibizumab(Fixed dosing regimen) and JL14002 monoclonal antibody(PRN) in people with Wet Age-related Macular Degeneration, run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of JL14002 compared to Lucentis® in subjects with wAMD. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
JL14002 monoclonal antibody(Fixed dosing regimen), Ranibizumab(Fixed dosing regimen) and JL14002 monoclonal antibody(PRN)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
443 participants
Where
1 siteChina
Study dates
1 Mar 2022to 23 Sep 2024
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Ability to understand and voluntarily sign the informed consent form, and willingness to comply with all trial protocol-specified follow-up visits.
  • 2.Aged 50 to 80 years (inclusive), male or female. 3.The study eye must meet all the following criteria:
  • Diagnosis of wet Age-related Macular Degeneration (wAMD) with active disease at screening, defined by the presence of ≥1 of the following macular lesions:a) Intraretinal fluid; b) Intraretinal lipid exudation or subretinal fluid; c) Subretinal fluid; d) Subretinal hemorrhage; e) Retinal pigment epithelial detachment (PED).
  • Best Corrected Visual Acuity (BCVA) score between 75 and 24 letters (inclusive) as measured by ETDRS chart at screening (Snellen equivalent: 20/32 to 20/320).

Who cannot join

  • Previous treatment with photodynamic therapy (PDT) or any combination therapy involving PDT in either eye.
  • Any intravitreal anti-VEGF therapy (e.g., bevacizumab, aflibercept, ranibizumab, conbercept) in either eye within 90 days before the first dose.
  • Previous ocular surgery in the study eye, including but not limited to: macular translocation, glaucoma filtration surgery, subfoveal laser photocoagulation, vitrectomy, transpupillary thermotherapy, or any other surgery for AMD.
  • Subretinal hemorrhage in the study eye involving the fovea, with an area ≥4 disc areas (DA) on FFA.
  • Presence of subfoveal fibrosis, scar, geographic atrophy, or dense subfoveal hard exudates in the study eye.
  • Choroidal neovascularization (CNV) in the study eye due to causes other than wAMD (e.g., ocular histoplasmosis, pathologic myopia, angioid streaks, trauma).
Show all 38Show fewer
  • Any concurrent ocular disease (other than wAMD) or history thereof in the study eye that could confound assessment of the macula or central vision (e.g., diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, macular hole, epiretinal membrane, vitreomacular traction).
  • Any ocular condition in the study eye that, per investigator judgment, may require treatment during the study, lead to vision loss, or preclude adequate fundus imaging/assessment (e.g., significant media opacity, pupillary miosis).
  • Intraocular or periocular surgery in the study eye within 90 days before the first dose (excluding uncomplicated eyelid surgery >28 days prior). Parafoveal laser or cataract surgery within this period is excluded.
  • History of corneal transplantation in the study eye.
  • Active intraocular, extraocular, or periocular inflammation in either eye at screening.
  • Active ocular infection in either eye at screening (e.g., conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis).
  • History of idiopathic or autoimmune-associated uveitis in either eye.
  • Current vitreous hemorrhage in the study eye or history thereof within 28 days before the first dose.
  • Aphakia (excluding pseudophakia) or rupture of the posterior lens capsule in the study eye (except status post YAG laser capsulotomy).
  • Advanced glaucoma or optic neuropathy involving/threatening the central visual field in the study eye; or uncontrolled intraocular pressure (IOP ≥25 mmHg despite treatment).
  • High myopia (spherical equivalent ≤ -6 diopters) in the study eye.
  • Current or anticipated use of medications with known retinal, lens, or optic nerve toxicity (e.g., chloroquine/hydroxychloroquine, ethambutol, tamoxifen, phenothiazines).
  • History of severe allergic reaction to biologics, or known hypersensitivity to JL14002, ranibizumab, fluorescein/ICG, mydriatics, or related topical agents.
  • Active systemic infection requiring therapy.
  • Poorly controlled autoimmune disease.
  • Any condition that, per investigator judgment, poses a high risk for complications or confounds results (e.g., uncontrolled hypertension [SBP≥160 or DBP≥100 mmHg], HbA1c ≥8%).
  • Recent corticosteroid use meeting any of the following:
  • 1) Study eye (intraocular/subconjunctival): Intermediate-/short-acting (e.g., triamcinolone) within 90 days; long-acting/sustained-release (e.g., dexamethasone implant) within 180 days.
  • 2) Study eye (periocular): Injection within 28 days before screening; topical ocular use for ≥30 continuous days within 90 days.
  • 3) Systemic: Within 5 days before screening or anticipated need during study (excluding topical, inhaled, intranasal, intra-articular, or short-term oral [<2 weeks] use).
  • 24.Fellow eye BCVA <24 letters (Snellen <20/320) or presence of other potentially blinding conditions.
  • 25.Systemic anti-VEGF therapy within 90 days before the first dose. 26.History of malignancy within 5 years (exceptions: adequately treated basal/squamous cell skin cancer, carcinoma in situ of cervix/breast).
  • 27.Clinically significant abnormal liver or renal function:1) ALT or AST ≥2 × ULN;2) Creatinine or BUN ≥1.5 × ULN 28.Coagulopathy (PT ≥ ULN +3 sec; aPTT ≥ ULN +10 sec). 29.Positive serology for:
  • Hepatitis B: Positive for Hepatitis B surface antigen (HBsAg). Note: Subjects with positive HBsAg but undetectable Hepatitis B virus deoxyribonucleic acid (HBV-DNA) are eligible.
  • Hepatitis C: Positive for Hepatitis C virus (HCV) antibody. Note: Subjects with positive HCV antibody but undetectable HCV ribonucleic acid (HCV-RNA) are eligible.
  • Positive syphilis screening [Treponema pallidum antibody (Tp-Ab)].
  • Known positive history or positive screening for Human Immunodeficiency Virus (HIV).
  • 30.Pregnancy, lactation, or unwillingness to use highly effective contraception from screening until 180 days after last dose.
  • 31.Participation in another investigational drug/device trial within 90 days before screening (excluding vitamin/mineral studies).
  • 32.Uncontrolled major systemic illness at screening; history of stroke, myocardial infarction, or cerebral infarction within 180 days.
  • 33.Major surgery within 1 month before first dose, or presence of unhealed wounds/ulcers/fractures.
  • 34.Any other condition that, in the investigator's opinion, renders the subject unsuitable for trial participation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing

Other trials in China

About this study

Official title: A Randomized, Double-masked, Multicenter, Parallel Group, Phase 3 Clinical Trial to Compare the Efficacy and Safety of JL14002 Monoclonal Antibody Injection Versus Ranibizumab Injection in Patients With Neovascular (Wet) Age-Related Macular Degeneration (wAMD)

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of JL14002 compared to Lucentis® in subjects with wAMD.

Read the detailed description

Subjects will be randomised in a 2:1:1 ratio into the JL14002 Experimental Arm, Active Comparator Arm 1, and Active Comparator Arm 2. During the first 12 weeks, all subjects will receive fixed dosing at intervals of every 4 weeks (0.5 mg per dose), with a total of three consecutive doses. Subjects in the JL14002 experimental arm will receive JL14002 monoclonal antibody injection, while those in active comparator arm 1 and active comparator arm 2 will receive ranibizumab injection. Starting from week 12, all subjects will transition to a pro re nata (PRN) dosing regimen. Based on the PRN criteria assessed by the investigator, subjects in the JL14002 experimental arm and active comparator arm 1 will receive JL14002 monoclonal antibody injection as needed, while subjects in active comparator arm 2 will receive ranibizumab injection as needed. All subjects will be required to return to the study site every 4 weeks for safety and efficacy assessments.

Being tested
JL14002 monoclonal antibody(Fixed dosing regimen), Ranibizumab(Fixed dosing regimen), JL14002 monoclonal antibody(PRN), Ranibizumab(PRN)
Keywords
Phase3, wAMD, Ranibizumab, Lucentis

What participants receive

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

  • JL14002 monoclonal antibody(Fixed dosing regimen)Drug

    Also called Intravitreal (IVT) injection

    For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg JL14002 once every 4 weeks for a total of 3 consecutive doses.

  • Ranibizumab(Fixed dosing regimen)Drug

    Also called Intravitreal (IVT) injection

    For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg Ranibizumab once every 4 weeks for a total of 3 consecutive doses.

  • JL14002 monoclonal antibody(PRN)Drug

    Also called Intravitreal (IVT) injection, pro re nata (PRN)

    From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen. Patients will receive 0.5 mg of JL14002 monoclonal antibody injection as needed, based on pre-specified retreatment criteria.

  • Ranibizumab(PRN)Drug

    Also called Intravitreal (IVT) injection, pro re nata (PRN)

    From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen. Patients will receive 0.5 mg of Ranibizumab injection as needed, based on pre-specified retreatment criteria.

Study groups in NCT07389577
Study groupRoleWhat they receive
JL14002 Experimental Arm(Drug: JL14002 monoclonal antibody)ExperimentalFor the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg JL14002 once every 4 weeks for a total of 3 consecutive doses. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria.
Receives: Drug: JL14002 monoclonal antibody(Fixed dosing regimen); Drug: JL14002 monoclonal antibody(PRN)
Active Comparator Arm 1 (Drug: Ranibizumab→JL14002 monoclonal antibody)Active comparatorFor the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg Ranibizumab once every 4 weeks for a total of 3 consecutive doses. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria., subjects will receive the JL14002 treatment
Receives: Drug: JL14002 monoclonal antibody(Fixed dosing regimen); Drug: JL14002 monoclonal antibody(PRN)
Active Comparator Arm 2 (Drug:Ranibizumab)Active comparatorFor the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg Ranibizumab once every 4 weeks for a total of 3 consecutive doses. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria.
Receives: Drug: Ranibizumab(Fixed dosing regimen); Drug: Ranibizumab(PRN)

What is being measured

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

  1. Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12

    Measured: Baseline (Day 0), Week 12

Secondary outcomes (5)

  1. Proportion of subjects who gained at least 5,10 and 15 letters and lose 15 letters baseline to week 12,week 24 and week 52

    Measured: Baseline (Day 0), Week 12, Week 24, Week 52

  2. Change From Baseline in CRT(central retina thickness) by visit

    Measured: Baseline (Day 0), Week 12, Week 24, Week 52

  3. Change from baseline in CNV area from baseline to week 12 and week 52

    Measured: Baseline (Day 0), Week 12, Week 52

  4. BCVA Change From Baseline by visit

    Measured: Baseline (Day 0), Week 24, Week 52

  5. Incidence of drug-related ocular and systemic adverse reactions at Week 12, Week 24, and Week 52.

    Measured: Baseline (Day 0), Week 12, 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 posted5 Feb 2026
  2. Study start1 Mar 2022
  3. Primary completion20 Dec 2023
  4. Study completion23 Sep 2024

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07389577
Sponsor's protocol ID
JechoBiopharm
Other IDs
CTR20213179
Status last verified
Jan 2026
First submitted
29 Jan 2026
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
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 JL14002 monoclonal antibody(Fixed dosing regimen), Ranibizumab(Fixed dosing regimen) and JL14002 monoclonal antibody(PRN) in people with Wet Age-related Macular Degeneration, run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.

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 4 inclusion and 38 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: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 (time frame: Baseline (Day 0), Week 12). 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 NCT07389577.

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 5 Feb 2026.

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