A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD)

NCT ID: NCT05345236

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2022-01-25

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.

Conditions

Wet Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aflibercept

Intervention Type: DRUG

Intravitreal (IVT) injection

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.

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

Intravitreal (IVT) injection

Interventions

Aflibercept

Intravitreal (IVT) injection

Intervention Type: DRUG

Other Intervention Names

Eylea， VEGF-Trap

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

youxin chen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37987893 (View on PubMed)

Other Identifiers

QL1207-002

Identifier Type: -

Identifier Source: org_study_id