A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD)

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT05345236
Phase
PHASE3
Status
Completed

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of QL1207 compared to Eylea® in subjects with wet AMD.

Key Dates

Start date
Aug 19, 2019
Status verified
Apr 2022
Primary completion
Jan 25, 2022
Completion
Jan 25, 2022

Study Design

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

Arms

  • Experimental: QL1207
    Subjects randomized into QL1207 group will receive QL1207 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
  • Active Comparator: Eylea®
    Subjects randomized into Eylea® group will receive Eylea® 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.

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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