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

NCT07389577 | Completed Phase 3 DMC

• 2 other identifiers: JechoBiopharmCTR20213179
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wet Age-related Macular Degeneration

Keywords

Phase3; wAMD; Ranibizumab; Lucentis

Outcome Measures

Primary Outcomes (1)

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

  Baseline (Day 0), Week 12

Secondary Outcomes (5)

• 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

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

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

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

• Change from baseline in CNV area from baseline to week 12 and week 52

  Baseline (Day 0), Week 12, Week 52

• BCVA Change From Baseline by visit

  Baseline (Day 0), Week 24, Week 52

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

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

Study Arms (3)

JL14002 Experimental Arm(Drug: JL14002 monoclonal antibody)

EXPERIMENTAL

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. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria.

Drug: JL14002 monoclonal antibody(Fixed dosing regimen); Drug: JL14002 monoclonal antibody(PRN)

Active Comparator Arm 1 (Drug: Ranibizumab→JL14002 monoclonal antibody)

ACTIVE COMPARATOR

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. 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

Drug: JL14002 monoclonal antibody(Fixed dosing regimen); Drug: JL14002 monoclonal antibody(PRN)

Active Comparator Arm 2 (Drug:Ranibizumab)

ACTIVE COMPARATOR

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. From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen based on pre-specified retreatment criteria.

Drug: Ranibizumab(Fixed dosing regimen); Drug: Ranibizumab(PRN)

Interventions

JL14002 monoclonal antibody(PRN) DRUG

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.

Also known as: Intravitreal (IVT) injection, pro re nata (PRN)

Active Comparator Arm 1 (Drug: Ranibizumab→JL14002 monoclonal antibody); JL14002 Experimental Arm(Drug: JL14002 monoclonal antibody)

Ranibizumab(PRN) DRUG

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.

Also known as: Intravitreal (IVT) injection, pro re nata (PRN)

Active Comparator Arm 2 (Drug:Ranibizumab)

JL14002 monoclonal antibody(Fixed dosing regimen) DRUG

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.

Also known as: Intravitreal (IVT) injection

Active Comparator Arm 1 (Drug: Ranibizumab→JL14002 monoclonal antibody); JL14002 Experimental Arm(Drug: JL14002 monoclonal antibody)

Ranibizumab(Fixed dosing regimen) DRUG

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.

Also known as: Intravitreal (IVT) injection

Active Comparator Arm 2 (Drug:Ranibizumab)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and voluntarily sign the informed consent form, and willingness to comply with all trial protocol-specified follow-up visits.
• 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).

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2022
• Primary Completion: December 20, 2023
• Study Completion: September 23, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)