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

NCT ID: NCT04993352

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2023-03-13

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)

Detailed Description

This is a Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects with wet Age related Macular Degeneration (wAMD).The study will be conducted in approximately 6 sites in China.

Conditions

Age Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLX04-O

Biologic recombinant anti-VEGF humanized monoclonal antibody.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Capable to fully understand and sign the informed consent form (ICF).

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

3. 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).

4. The total lesion area (including bleeding, scar and neovascularization) of the study eye ≤12 disc area (DA).

5. The BCVA letters between 15 and 78, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

6. 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, or pathological myopia, etc.).

2. 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.

3. 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.

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

5. 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.

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 (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.).

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 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.

10. 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.

11. 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.

12. Subconjunctival or intraocular or systemic use of corticosteroids within 3 months (including subconjunctival or intraocular long-acting implant within 6 months).

13. 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.

14. 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.

15. Pregnancy or lactation.

16. Men or women fail to meet both of the following ones: 1) women must have a negative serum pregnancy test result within 14 days prior to initiation of the study intervention; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of the study intervention. Effective contraceptive methods include bilateral tubal ligation, male sterilization, established physical contraception and copper intrauterine devices (IUDs).

17. Stroke or myocardial infarction within 6 months prior to dose 1, uncontrolled hypertension (systolic blood pressure≥160 mmHg, or diastolic blood pressure ≥100 mmHg), etc.

18. Uncontrolled diabetes (defined as HbA1c>10.0%).

19. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than the ULN, and is clinically significant in the opinion of the Investigator.

20. Abnormal coagulation function（prothrombin time ≥ 3 seconds over ULN, activated partial thromboplastin time ≥ 10 seconds over ULN）

21. Active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to dose 1.

22. Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases.

23. Current treatment for active systemic infection, or history of recurrent serious infections.

24. Known active or suspected autoimmune diseases, requiring systemic immunosuppressive therapy.

25. Positive for syphilis screening test or positive for human immunodeficiency virus (HIV) screening test.

26. Known allergy to any component of the study intervention or history of allergy to fluorescein(only for patients who cannot undergo OCT-A examination but have to undergo ICGA examination) or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.

27. Participant who has been diagnosed to be COVID-19 within 1 month prior to dose 1 or who has received COVID-19 vaccine within 1week prior to dose 1.

28. In the Investigator's judgment, there is evidence of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications, or other conditions considered not amenable to this study.

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

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

XuZhou Central Hospital

Xuzhou, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36124180 (View on PubMed)

Other Identifiers

HLX04-O-wAMD-CN01

Identifier Type: -

Identifier Source: org_study_id