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This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of QL1207 compared to Eylea® in subjects with wet AMD.
Subjects will be randomised in a 1:1 ratio to receive either QL1207 or Eylea® (administered via intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks ) . Subjects will be administered the study drug up to week 48, and the last assessment will be done at Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1207 | Experimental | Subjects randomized into QL1207 group will receive QL1207 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. |
|
| Eylea® | Active Comparator | Subjects randomized into Eylea® group will receive Eylea® 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Intravitreal (IVT) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 | Baseline (Day 0), Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who gained at least 5,10 and 15 lettersbaseline to week 12,week 24 and week 52 | Baseline (Day 0), Week 12, Week 24, Week 52 | |
| Change From Baseline in CRT(central retina thickness) by visit | Baseline (Day 0), week 4, week 8, Week 12, Week 24, Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
Study eye:
Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea
Scar, fibrosis, or atrophy involving the centre of the fovea
Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia
Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP
Current vitreous haemorrhage within 30days before randomization
Any other intraocular surgery or periocular surgery within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation.
Uncontrolled ocular hypertension (defined as intraocular pressure [IOP] ≥ 25 mmHg despite treatment with anti-glaucoma medication) at Screening
Either eye:
Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment
Any previous systemic anti-VEGF treatment
History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD
Active or suspected ocular and periocular infection at Screening or at randomisation
History of idiopathic or autoimmune-associated uveitis
Other:
Known allergic reactions and/or hypersensitivity to any component of Eylea or QL1207 or allergy to the fluorescein sodium for injection in angiography
Uncontrolled systemic hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg on optimal medical regimen)
Any previous systemic anti-VEGF treatment
Women of childbearing potential who are pregnant, planning to become pregnant, lactating, or not using adequate birth control, as specified in protocol. For women of childbearing potential, a serum pregnancy test must result negative at Screening.
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| Name | Affiliation | Role |
|---|---|---|
| youxin chen, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37987893 | Derived | Li B, Fan K, Zhang T, Wu Z, Zeng S, Zhao M, Ren Q, Zheng D, Wang L, Liu X, Han M, Song Y, Ye J, Pei C, Yi J, Wang X, Peng H, Zhang H, Zhou Z, Liang X, Yu F, Wu M, Li C, Lei C, Hao J, Tang L, Yuan H, Cai S, Li Q, Zhong J, Li S, Liu L, Ke M, Wang J, Wang H, Zhu M, Wang Z, Yan Y, Wang F, Chen Y. Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial. Ophthalmol Ther. 2024 Jan;13(1):353-366. doi: 10.1007/s40123-023-00836-4. Epub 2023 Nov 21. |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| BCVA Change From Baseline by visit | Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 |
| Change from baseline in CNV area from baseline to week 12, week 24 and week 52 | Baseline (Day 0), Week 12, Week 24, Week 52 |