CompletedPhase 3

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

China443 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range50 Years – 80 Years

SexALL

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Inclusion criteria

✓.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).

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).

What they're measuring

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

Timeframe: Baseline (Day 0), Week 12

Trial details

NCT IDNCT07389577

SponsorJecho Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-20

View on ClinicalTrials.gov More Wet Age-related Macular Degeneration trials