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

Sponsor
Jecho Biopharmaceuticals Co., Ltd.
Study ID
NCT07389577
Phase
PHASE3
Status
Completed

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Feb 5, 2026
Start date
Mar 1, 2022
Status verified
Jan 2026
Primary completion
Dec 20, 2023
Completion
Sep 23, 2024

Study Design

Enrollment
443 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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
  • Active Comparator: 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.

Primary Outcome Measure

Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 [ Time Frame: Baseline (Day 0), Week 12 ]

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