Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New eye drug shows promise in battle against blinding disease

NCT ID NCT07389577

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called JL14002 against a standard treatment (ranibizumab) for wet age-related macular degeneration, a leading cause of vision loss. 443 adults aged 50-80 with active disease received injections into the eye. The main goal was to see if JL14002 improved vision as well as the standard drug over 12 weeks, with follow-up for a year. The approach aims to control the disease and preserve sight.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

443 people

The number who actually took part.

Started

Mar 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: 1. 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). 2. 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). Exclusion Criteria: 1. Previous treatment with photodynamic therapy (PDT) or any combination therapy involving PDT in either eye. 2. Any intravitreal anti-VEGF therapy (e.g., bevacizumab, aflibercept, ranibizumab, conbercept) in either eye within 90 days before the first dose. 3. 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. 4. Subretinal hemorrhage in the study eye involving the fovea, with an area ≥4 disc areas (DA) on FFA. 5. Presence of subfoveal fibrosis, scar, geographic atrophy, or dense subfoveal hard exudates in the study eye. 6. Choroidal neovascularization (CNV) in the study eye due to causes other than wAMD (e.g., ocular histoplasmosis, pathologic myopia, angioid streaks, trauma). 7. 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). 8. 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). 9. 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. 10. History of corneal transplantation in the study eye. 11. Active intraocular, extraocular, or periocular inflammation in either eye at screening. 12. Active ocular infection in either eye at screening (e.g., conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis). 13. History of idiopathic or autoimmune-associated uveitis in either eye. 14. Current vitreous hemorrhage in the study eye or history thereof within 28 days before the first dose. 15. Aphakia (excluding pseudophakia) or rupture of the posterior lens capsule in the study eye (except status post YAG laser capsulotomy). 16. Advanced glaucoma or optic neuropathy involving/threatening the central visual field in the study eye; or uncontrolled intraocular pressure (IOP ≥25 mmHg despite treatment). 17. High myopia (spherical equivalent ≤ -6 diopters) in the study eye. 18. Current or anticipated use of medications with known retinal, lens, or optic nerve toxicity (e.g., chloroquine/hydroxychloroquine, ethambutol, tamoxifen, phenothiazines). 19. History of severe allergic reaction to biologics, or known hypersensitivity to JL14002, ranibizumab, fluorescein/ICG, mydriatics, or related topical agents. 20. Active systemic infection requiring therapy. 21. Poorly controlled autoimmune disease. 22. 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%). 23. 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: 1. 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. 2. Hepatitis C: Positive for Hepatitis C virus (HCV) antibody. Note: Subjects with positive HCV antibody but undetectable HCV ribonucleic acid (HCV-RNA) are eligible. 3. Positive syphilis screening \[Treponema pallidum antibody (Tp-Ab)\]. 4. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Wet age related macular degeneration are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.