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
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