A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QL1207 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. |
Drug: Aflibercept
Intravitreal (IVT) injection
Other Names:
|
| Active Comparator: Eylea® 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. |
Drug: Aflibercept
Intravitreal (IVT) injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 [Baseline (Day 0), Week 12]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 50 years male and female
-
Treatment naïve, *active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye
-
CNV area ≥50% of total lesion size
-
Total lesion area ≤ 12.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye
-
BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using ETDRS charts in the study eye
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Fellow eye is not expected to need any anti-VEGF treatment for the duration of study participation.
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
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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
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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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: youxin chen, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QL1207-002