A Phase 3 Two-part Study to Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04740671
Collaborator
(none)
388
1
2
27.5
14.1

Study Details

Study Description

Brief Summary

This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a Phase 3, Two-part (Open-label Followed by Randomized Double-masked Active Controlled) Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection with Ranibizumab in Subjects with wet Age-related Macular Degeneration (wAMD). This study will be conducted in approximately 90 sites in different countries or regions, including Australia, China, and Europe.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
388 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Two-part (Open-label Followed by Randomized Double-masked Active Controlled) Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection With Ranibizumab in Subjects With wAMD
Actual Study Start Date :
Feb 28, 2021
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jun 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HLX04-O

Biologic recombinant anti-VEGF humanized monoclonal antibody

Drug: HLX04-O
Biologic recombinant anti-VEGF humanized monoclonal antibody, developed by Shanghai Henlius Biotech, Inc.

Active Comparator: Ranibizumab

Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Drug: ranibizumab
Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Outcome Measures

Primary Outcome Measures

  1. Mean change from baseline in BCVA at at Week 36 [up to at Week 36]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Secondary Outcome Measures

  1. Mean change from baseline in BCVA at Week 12, 24 and 48 [up to Week 12, 24 and 48]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  2. Mean change in BCVA over time [up to Months 12]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  3. Proportion of patients gaining at least 15 letters in the BCVA at Week 12, 24, 36 and 48 [up to Week 12, 24, 36 and 48]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  4. Proportion of patients gaining at least 10 letters in the BCVA at Week 12, 24, 36 and 48 [up to Week 12, 24, 36 and 48]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  5. Proportion of patients gaining at least 5 letters in the BCVA at Week 12, 24, 36 and 48 [up to Week 12, 24, 36 and 48]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  6. • Mean change from baseline in size of CNV and total area of fluorescein leakage from CNV on FA at Week 12, 36 and 48 (as measured by the Reading Center) [up to Week 12, 36 and 48]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  7. • Mean change from baseline in CRT on OCT at Week 12, 24, 36 and 48 (as measured by the Reading Center) [up to week 12, 24, 36 and 48]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  8. Change from baseline in NEI VFQ-25 scale score at Week 12, 36, and 48. [up to Week 12, 36, and 48]

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Capable to understand and sign the informed consent form (ICF) as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

  2. Women or men aged ≥50 years when signing the ICF.

  3. In the Investigator's judgment, willing and able to complete all visits and assessments adhering to the prohibitions and restrictions specified in this protocol.

  4. Newly diagnosed or recurrently, active subfoveal or juxtafoveal CNV lesions secondary to age-related macular degeneration in the study eye. Active CNV was defined as leakage on fluorescein angiography (FA) and subretinal or intraretinal fluid on optical coherence tomography (OCT) with confirmation of the reading center during screening.

  5. The total lesion area (including bleeding, scar and neovascularization) of the study eye ≤12 disc area (DA) with confirmation of the reading center before randomization.

  6. The BCVA letters between 24 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  7. Participants' fellow (non-study) eyes must have had a BCVA of 24 letters or better.

  8. Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm the diagnosis.

Exclusion Criteria:
  1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis or atrophy involving the fovea, or CNV due to other causes in the study eye (e.g., ocular histoplasmosis, trauma, pathological myopia, or polypoidal choroidal vasculopathy (PCV), etc.) with confirmation of the reading center.

  2. The fellow (non study) eye needs anti-VEGF IVT injection (e.g. CNV due to wAMD, trauma, pathological myopia or PCV, retina vein occlusion, diabetic macular edema, etc) in the next 3 months after randomization, in the investigator's judgment.

  3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation ≥30 days prior to first dose) in the study eye.

  4. Active or recent (within 1 month prior to dose 1) intraocular, extraocular or periocular infection (including conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated uveitis in either eye.

  5. Vitreous hemorrhage in the study eye within 3 months prior to dose 1.

  6. Corneal dystrophy or history of corneal transplantation, scleral softening or history of scleral softening, history of rhegmatogenous retinal detachment or macular hole (Stage II, III or IV) in the study eye.

  7. Uncontrolled glaucoma in the study eye (defined as IOP ≥25 mmHg despite treatment with antiglaucoma medication), and/or glaucoma filtering surgery (e.g., trabeculectomy, scleral nipping, non-penetrating trabeculectomy, etc.)

  8. Equivalent spherical diopter of the study eye ≥-8D. For participants who had undergone refractive correction or cataract surgery, the equivalent spherical diopter of the study eye before surgery ≥-8D.

  9. Estimated by the Investigator, any concurrent intraocular condition except wAMD (e.g., diabetic retinopathy, dry AMD, retina vein occlusion, uveitis, angioid streaks, retinal detachment, macular hole, macular edema, amblyopia, central serous chorioretinopathy, etc.) in the study eye that limited the potential to gain visual acuity upon treatment with the investigational product, or could have required medical or surgical intervention during the study to prevent or treat visual loss.

Prior/Concomitant Treatment

  1. Underwent intraocular surgery including verteporfin photodynamic therapy (PDT), transpupillary thermotherapy, macular translocation, vitrectomy, laser photocoagulation in macular area, other surgery in macular area or surgery to treat AMD.

  2. Previous extraocular or periocular surgery within 1 month prior to dose 1, or current unhealed wound, moderate or severe ulcer or fracture in the study eye.

  3. Subconjunctival or intraocular or systemic use of corticosteroids within 3 months (including subconjunctival or intraocular long-acting implant within 6 months) prior to dose 1 in the study eye.

  4. Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug into either eye or other ocular use of anti-VEGF drug within 3 months prior to dose 1.

  5. Participated in any drug (other than vitamins and minerals) or device clinical trials 3 months or the duration of 5 half-lives of the study drug (which is longer) before the first dose and have used the test drug or received device treatment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lions Eye Institute Nedlands Western Australia Australia WA 6009

Sponsors and Collaborators

  • Shanghai Henlius Biotech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Henlius Biotech
ClinicalTrials.gov Identifier:
NCT04740671
Other Study ID Numbers:
  • HLX04-O-wAMD
First Posted:
Feb 5, 2021
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022