A Clinical Study of QL1207H Injection Versus Aflibercept for Neovascular Age-related Macular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
QL1207H injection
DrugDuring 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 mg
DrugDuring 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.
Treatment groups
356 Participants
are divided into 2 treatment groupsGroup A: QL1207H injection groupExperimental treatment 1 intervention
Group B: Aflibercept 8 mg groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in BCVA at Week 12
Time frame
Week 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: