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

Primary Purpose

Wet Age-related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QL1207

Eylea®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to 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
Change From Baseline in CRT(central retina thickness) by visit
BCVA Change From Baseline by visit
Change from baseline in CNV area from baseline to week 12, week 24 and week 52

Full Information

First Posted
April 19, 2022
Last Updated
April 19, 2022
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05345236
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QL1207
Arm Type
Experimental
Arm Description
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.
Arm Title
Eylea®
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea， VEGF-Trap
Intervention Description
Intravitreal (IVT) injection
Primary Outcome Measure Information:
Title
Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
Time Frame
Baseline (Day 0), Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects who gained at least 5,10 and 15 lettersbaseline to week 12,week 24 and week 52
Time Frame
Baseline (Day 0), Week 12, Week 24, Week 52
Title
Change From Baseline in CRT(central retina thickness) by visit
Time Frame
Baseline (Day 0), week 4, week 8, Week 12, Week 24, Week 52
Title
BCVA Change From Baseline by visit
Time Frame
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
Title
Change from baseline in CNV area from baseline to week 12, week 24 and week 52
Time Frame
Baseline (Day 0), Week 12, Week 24, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
youxin chen, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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