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

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07489586
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility Criteria

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

Interventions

  • QL1207H injection — DRUG
    During 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.
  • Aflibercept 8 mg — DRUG
    During 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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL1207H injection group
  • Active Comparator: Aflibercept 8 mg group

Primary Outcome Measure

Change from baseline in BCVA at Week 12 [ Time Frame: Week 12 ]

Central Contacts

Related Studies