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

NCT07489586 | Not Yet Recruiting Phase 3

• 1 other identifier: QL1207H-301
• Study Type: interventional
• Target: 356
• Locations: 0 countries
• Sites: N/A

Brief 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

Neovascular Age-Related Macular Degeneration (nAMD)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in BCVA at Week 12

  Week 12

Study Arms (2)

QL1207H injection group

EXPERIMENTAL

Drug: QL1207H injection

Aflibercept 8 mg group

ACTIVE COMPARATOR

Drug: Aflibercept 8 mg

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.

QL1207H injection group

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.

Aflibercept 8 mg group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Wangwang Zhi, Master

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03