Neovascular Age-Related Macular Degeneration (nAMD)
Conditions
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.
Interventions
DRUGQL1207H 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.
DRUGAflibercept 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.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BCVA at Week 12 | Week 12 |
Contacts
CONTACTWangwang Zhi, Master
Outcome results
None listed