Neovascular Age-Related Macular Degeneration (nAMD)Phase 3NCT07489586
A Clinical Study of QL1207H Injection Versus Aflibercept for Neovascular Age-related Macular Degeneration
A Phase 3 study testing QL1207H injection and Aflibercept 8 mg in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Qilu Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD)
- What is being tested?
- QL1207H injection and Aflibercept 8 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- QL1207H injection, Aflibercept 8 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1207H injectionDrug
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 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| QL1207H injection group | Experimental | Not described Receives: Drug: QL1207H injection |
| Aflibercept 8 mg group | Active comparator | Not described Receives: Drug: Aflibercept 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BCVA at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489586
- Sponsor's protocol ID
- QL1207H-301
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07489586
- Acronym / sponsor ID
- QL1207H-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1207H injection group | Experimental | Drug: QL1207H injection |
| Aflibercept 8 mg group | Active comparator | Drug: Aflibercept 8 mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1207H injectionDuring 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. | Drug | QL1207H injection group |
| Aflibercept 8 mgDuring 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. | Drug | Aflibercept 8 mg group |
Primary outcome
Change from baseline in BCVA at Week 12
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Related trials for Neovascular Age-Related Macular Degeneration (nAMD)
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
RecruitingPhase 3
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD)
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingPhase 3
A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration, nAMD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL1207H injection and Aflibercept 8 mg in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wangwang Zhi, Master (+86-17761717313, wangwang.zhi@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BCVA at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.