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NCT Number: NCT07489586

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in BCVA at Week 12

    Time frame: Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Wangwang Zhi, Master

CONTACT

[email protected]

+86-17761717313

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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