A Clinical Study of QL1207H Injection Versus Aflibercept... | NCT07489586

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

NCT07489586

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Mar 24, 2026Actual

Enrollment

356Estimated

Phase

Phase 3

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

QL1207H injection
Aflibercept 8 mg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Mar 18, 2026

First Submission Date that Met QC Criteria

Mar 18, 2026

First Posted Date

Mar 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

356Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QL1207H injection group	Experimental		Drug: QL1207H injection
Aflibercept 8 mg group	Active Comparator		Drug: Aflibercept 8 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Change from baseline in BCVA at Week 12		Week 12

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided