Clinical trial NCT05345236: A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD)
Official title: A Phase III Randomised, Double-masked, Parallel Group Study to Compare the Efficacy and Safety Between QL1207 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Wet Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wet Age-related Macular Degeneration
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 366
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 50 years male and female
2. Treatment naïve, \*active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye
3. CNV area ≥50% of total lesion size
4. Total lesion area ≤ 12.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye
5. BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using ETDRS charts in the study eye
6. Fellow eye is not expected to need any anti-VEGF treatment for the duration of study participation.

Exclusion Criteria:

Study eye:

1. 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
2. Scar, fibrosis, or atrophy involving the centre of the fovea
3. Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia
4. Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP
5. Current vitreous haemorrhage within 30days before randomization
6. 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.
7. Uncontrolled ocular hypertension (defined as intraocular pressure \[IOP\] ≥ 25 mmHg despite treatment with anti-glaucoma medication) at Screening

   Either eye:
8. Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment
9. Any previous systemic anti-VEGF treatment
10. 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
11. Active or suspected ocular and periocular infection at Screening or at randomisation
12. History of idiopathic or autoimmune-associated uveitis

    Other:
13. Known allergic reactions and/or hypersensitivity to any component of Eylea or QL1207 or allergy to the fluorescein sodium for injection in angiography
14. Uncontrolled systemic hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg on optimal medical regimen)
15. Any previous systemic anti-VEGF treatment
16. 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.

Primary outcomes:
measure: Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
timeFrame: Baseline (Day 0), Week 12
Secondary outcomes:
measure: Proportion of subjects who gained at least 5,10 and 15 lettersbaseline to week 12,week 24 and week 52
timeFrame: Baseline (Day 0), Week 12, Week 24, Week 52
measure: Change From Baseline in CRT(central retina thickness) by visit
timeFrame: Baseline (Day 0), week 4, week 8, Week 12, Week 24, Week 52
measure: BCVA Change From Baseline by visit
timeFrame: 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
measure: Change from baseline in CNV area from baseline to week 12, week 24 and week 52
timeFrame: Baseline (Day 0), Week 12, Week 24, Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: youxin chen, MD
role: PRINCIPAL_INVESTIGATOR
References: