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

NCT07389577 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

DRUG

JL14002 monoclonal antibody(Fixed dosing regimen)

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.

DRUG

Ranibizumab(Fixed dosing regimen)

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.

DRUG

JL14002 monoclonal antibody(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.

DRUG

Ranibizumab(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.

Sponsors & Collaborators

  • Jecho Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-12-20
Completion
2024-09-23

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389577 on ClinicalTrials.gov