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)
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Jecho Biopharmaceuticals Co., Ltd.
- Enrollment
- 443
- Locations
- 1
- Primary Endpoint
- Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
JL14002 Experimental Arm(Drug: JL14002 monoclonal antibody)
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.
Intervention: JL14002 monoclonal antibody(Fixed dosing regimen) (Drug)
JL14002 Experimental Arm(Drug: JL14002 monoclonal antibody)
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.
Intervention: JL14002 monoclonal antibody(PRN) (Drug)
Active Comparator Arm 1 (Drug: Ranibizumab→JL14002 monoclonal antibody)
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
Intervention: JL14002 monoclonal antibody(Fixed dosing regimen) (Drug)
Active Comparator Arm 1 (Drug: Ranibizumab→JL14002 monoclonal antibody)
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
Intervention: JL14002 monoclonal antibody(PRN) (Drug)
Active Comparator Arm 2 (Drug:Ranibizumab)
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.
Intervention: Ranibizumab(PRN) (Drug)
Active Comparator Arm 2 (Drug:Ranibizumab)
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.
Intervention: Ranibizumab(Fixed dosing regimen) (Drug)
Outcomes
Primary Outcomes
Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
Time Frame: Baseline (Day 0), Week 12
Secondary Outcomes
- 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)