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

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.

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.