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Not Yet RecruitingNCT07489586

A Clinical Study of QL1207H Injection Versus Aflibercept for Neovascular Age-related Macular Degeneration

A Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of QL1207H Injection Versus Eylea® (Aflibercept, 114.3 mg/mL, 8 mg Per 70 μL) in Patients With Neovascular Age-Related Macular Degeneration

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
356 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of QL1207H injection versus aflibercept 8 mg in patients with neovascular age-related macular degeneration. The main question it aims to answer is: • Whether the efficacy and safety of QL1207H and aflibercept 8 mg are similar. Participants will receive injection once every 4 weeks for 3 consecutive doses, followed by injection once every 16 weeks at maximum. Researchers will compare QL1207H group and aflibercept 8 mg group to see if they are similar in improving best corrected visual acuity.

Conditions

Interventions

TypeNameDescription
DRUGQL1207H injectionDuring the first 8 weeks of the treatment period, the drug will be administered once every 4 weeks for 3 consecutive doses, followed by dosing once every 16 weeks at maximum.
DRUGAflibercept 8 mgDuring the first 8 weeks of the treatment period, the drug will be administered once every 4 weeks for 3 consecutive doses, followed by dosing once every 16 weeks at maximum.

Timeline

Start date
2026-03-01
Primary completion
2026-12-01
Completion
2027-08-01
First posted
2026-03-24
Last updated
2026-03-24

Source: ClinicalTrials.gov record NCT07489586. Inclusion in this directory is not an endorsement.