Not Yet RecruitingPhase 3

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

356 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. At least 50 years of age.
✓. Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
✓. Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
✓. Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
✓. BCVA ETDRS letter score of 78 to 24 in the study eye.

Exclusion criteria

✕. Causes of CNV other than nAMD in the study eye.
✕. Total lesion size \>12 disc areas; or subretinal hemorrhage that is at least 50% of the total lesion area, or if the blood under the fovea is 1 or more disc areas in size in the study eye.
✕. Scar, fibrosis, or atrophy involving the central subfield in the study eye.
✕. Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with antiglaucoma medication) in the study eye.
✕. Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.

What they're measuring

Change from baseline in BCVA at Week 12

Timeframe: Week 12

Trial details

NCT IDNCT07489586

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Wangwang Zhi, Master

+86-17761717313 wangwang.zhi@qilu-pharma.com

View on ClinicalTrials.gov More Neovascular Age-Related Macular Degeneration (nAMD) trials