Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD

NCT04993352 | Completed Phase 1

• 1 other identifier: HLX04-O-wAMD-CN01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HLX04-O administered every 4 weeks in participants with wet age-related macular degeneration (wAMD)

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Phase I: Safety events

  toxicity and causality (related to or possibly related to HLX04 O) that occurs within 4 weeks after the first treatment (single administration)

  week 4

• Phase 2: Mean change of letters from baseline in the BCVA at Week 12

  Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  Week 12

Secondary Outcomes (9)

• Phase I: HLX04-O systemic PK parameters following IVT administration of Dose 1 and Dose 4

  1 year

• Phase 2: Mean change of letters from baseline in the BCVA over time

  1 year

• Phase 2: Proportion of patients gaining at least 15/10/5 letters in the BCVA at Week 12, 24, 36 and 48

  1 year

• Phase 2: Mean change from baseline in the total area of CNV and the total area of fluorescein leakage on fluorescein angiography (FA) at Week 12, 24 and 48

  1 year

• Phase 2: Mean change from baseline in central retina thickness (CRT) on optical coherence tomography (OCT) at Week 12, 24, 36 and 48

  1 year

Study Arms (1)

HLX04-O

EXPERIMENTAL

Biologic recombinant anti-VEGF humanized monoclonal antibody.

Drug: recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection

Interventions

recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection DRUG

0.05mL (12.5mg/0.5mL/vial) HLX-04-O solution at a 4-week interval for intravitreal injection

HLX04-O

Eligibility Criteria

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

You may qualify if:

• Capable to fully understand and sign the informed consent form (ICF).
• Women or men aged ≥50 years when signing the ICF.
• Newly diagnosed or recurrently, active subfoveal or juxtafoveal CNV lesions secondary to AMD in the study eye. (Active CNV was defined as leakage on FA and subretinal or intraretinal fluid on OCT).
• The total lesion area (including bleeding, scar and neovascularization) of the study eye ≤12 disc area (DA).
• The BCVA letters between 15 and 78, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
• Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm the diagnosis.

You may not qualify if:

• 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, or pathological myopia, etc.).
• The fellow (non-study) eye needs anti-VEGF IVT injection (e.g. CNV due to wAMD, trauma, pathological myopia, retina vein occlusion, diabetic macular edema, etc) in the next 3 months, in the investigator's judgment.
• Active or recent (within 1 month prior to dose 1) intraocular, extraocular or periocular infection (including but not limited to conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated uveitis in either eye.
• Vitreous hemorrhage in study eye within 3 months prior to dose 1.
• Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation ≥1 month prior to first dose) in the study eye.
• 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.
• Uncontrolled glaucoma (defined as intraocular pressure \[IOP\] ≥25 mmHg despite treatment with antiglaucoma medication), and/or glaucoma filtering surgery (e.g., trabeculectomy, scleral nipping, non-penetrating trabeculectomy, etc.).
• 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.
• 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 epiretinal membrane, 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.
• 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.
• Previous intraocular or periocular surgery within 1 month prior to dose 1(including laser photocoagulation in juxtafoveal, cataract surgery, etc.), or current unhealed wound, moderate or severe ulcer or history of fracture in the study eye.
• Subconjunctival or intraocular or systemic use of corticosteroids within 3 months (including subconjunctival or intraocular long-acting implant within 6 months).
• Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug into either eye or other ocular use of anti-VEGF drug (ranibizumab, aflibercept or conbercept) within 3 months prior to dose 1.
• Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) prior to dose 1 and have used the test drug or received device treatment.
• Pregnancy or lactation.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

XuZhou Central Hospital

Xuzhou, Jiangsu, China

Location

Related Publications (1)

• Zhang Z, Wu Y, Lyu YL, Chang MQ, Xu QJ, Liu YM, Kang WY, Wang QY, Li CL. Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration. Int J Ophthalmol. 2022 Sep 18;15(9):1549-1553. doi: 10.18240/ijo.2022.09.20. eCollection 2022.

  PMID: 36124180 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Vascular Endothelial Growth Factor A

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Vascular Endothelial Growth Factors; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 6, 2021
• Study Start: July 15, 2021
• Primary Completion: July 7, 2022
• Study Completion: March 13, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)