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

NCT05345236 | Completed Phase 3

• 1 other identifier: QL1207-002
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12

  Baseline (Day 0), Week 12

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Drug: Aflibercept

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.

Drug: Aflibercept

Interventions

Aflibercept DRUG

Intravitreal (IVT) injection

Also known as: Eylea， VEGF-Trap

Eylea®; QL1207

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 37987893 DERIVED

MeSH Terms

Interventions

aflibercept

Study Officials

• youxin chen, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: August 19, 2019
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

CN (1)