Trials / Not Yet Recruiting
Not Yet RecruitingNCT07489586
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
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 356 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL1207H 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. |
| DRUG | Aflibercept 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-12-01
- Completion
- 2027-08-01
- First posted
- 2026-03-24
- Last updated
- 2026-03-24
Source: ClinicalTrials.gov record NCT07489586. Inclusion in this directory is not an endorsement.