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

March 18, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Causes of CNV other than nAMD in the study eye.
  2. 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.
  3. Scar, fibrosis, or atrophy involving the central subfield in the study eye.
  4. Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with antiglaucoma medication) in the study eye.
  5. Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL1207H injection group
Drug: QL1207H injection
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.
Active Comparator: Aflibercept 8 mg group
Drug: Aflibercept 8 mg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in BCVA at Week 12
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL1207H-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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