Status:
COMPLETED
A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD)
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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.
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, ...
Eligibility Criteria
Inclusion
- 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
- Fellow eye is not expected to need any anti-VEGF treatment for the duration of study participation.
Exclusion
- 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.
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT05345236
Start Date
August 19 2019
End Date
January 25 2022
Last Update
April 25 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China