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A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT03387566
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Huabo Biopharm Co., Ltd.

Study Description
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Brief Summary:
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1M, a human immunoglobulin Fc fusion protein containing domain 2 and flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with age-related macular degeneration (AMD).

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: HB002.1M Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Safety, Tolerability and Pharmacokinetic Profile Study of Intravitreous Injections of HB002.1M (a Vascular Endothelial Growth Factor Receptor Decoy) in Subjects With Neovascular Age-Related Macular Degeneration
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : March 23, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HB002.1M 0.3mg
Participants received a 0.3mg dose of HB002.1M via intravitreal (IVT) injection.
 Drug: HB002.1M
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Name: Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection
Experimental: HB002.1M 0.5mg
Participants received a 0.5mg dose of HB002.1M via intravitreal (IVT) injection.
 Drug: HB002.1M
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Name: Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection
Experimental: HB002.1M 1.0mg
Participants received a 1.0mg dose of HB002.1M via intravitreal (IVT) injection.
 Drug: HB002.1M
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Name: Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection
Experimental: HB002.1M 2.0mg
Participants received a 2.0mg dose of HB002.1M via intravitreal (IVT) injection.
 Drug: HB002.1M
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Name: Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection
Experimental: HB002.1M 3.0mg
Participants received a 3.0mg dose of HB002.1M via intravitreal (IVT) injection.
 Drug: HB002.1M
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Name: Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose) [ Time Frame: Up to 1 month after the single dose ]
    Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)


Secondary Outcome Measures :
  1. T1/2 (Terminal phase half life) after single dose [ Time Frame: 1 months ]
  2. Cmax (maximum observed concentration) after single dose [ Time Frame: 1 months ]
  3. AUC (Area Under Concentration-Time Curve) after single dose [ Time Frame: 1 months ]
  4. Immunogenicity Evaluation after single dose [ Time Frame: 2 months ]
    Incidence of ADA(Anti-Drug Antibody) response

  5. Change in Best Corrected Visual Acuity (BCVA) from baseline [ Time Frame: 1 month ]
  6. Change in central retinal thickness from baseline by Optical Coherence Tomography (OCT) [ Time Frame: 1 month ]
  7. Change in Choroidal Neovascularization (CNV) lesion area from baseline according to fluorescein angiogram [ Time Frame: 1 month ]
  8. Change of VEGF(Vascular Endothelial Growth Factor A) from baseline [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to provide written informed consent
  • Age 50 to 80 years old of either gender

  • Study eye must meet following requirements:

    • Active CNV lesions secondary to AMD
    • A lesion area <30 mm2 (12 disc areas) of any lesion type
    • BCVA ranging from 73-19 letters (20/32-20/400 Snellen equivalent), inclusive
    • Clear ocular media and adequate pupil dilation to permit good quality photographic imaging
  • Fellow eye must have had BCVA of 19 letters ( 20/400 Snellen equivalent) or better

Exclusion Criteria:

Any ophthalmic condition as below:

  • Presence of non-exudative AMD in the study eye as determined by investigator that affect macular examination, or presence of any diseases that affect central vision (including central retinal vein occlusion, diabetic retinopathy, uveitis, vascular fringes, pathological myopia, amotio retinae, macula hole etc.
  • Subretinal hemorrhage in the study eye the area of hemorrhage≥of total lesion area, or hemorrhage in central fovea≥1 disc area
  • Presence of scar, fibrosis or atrophy in central fovea of the study eye
  • CNV of the study eye associated with other ocular conditions , such as pathologic myopia, ocular histoplasmosis, posterior uveitis, or trauma
  • Anatomic damage to the center of the fovea including fibrosis and scarring making up >50% of total lesion area including the CNV in the study eye
  • History or presence of a retinal pigment epithelial tear, rhegmatogenous retinal detachment or macular hole in the study eye
  • History of study eye with intraocular or any ophthalmic surgery within prior 3 months (including Laser Photocoagulation at the para fovea , cataract etc.)
  • History of study eye with photodynamic therapy, macular translocation surgery trabeculectomy, Recess photocoagulation, thermal laser or external beam radiation in the study eye
  • History within 6 months of screening of following treatments(such as Macugen, Lucentis, Avastin, Eylea, Conbercpet, steroids etc)
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure of >25 mmHg despite treatment with maximal medical therapy)
  • History of any vitreous hemorrhage within 3 months

Any systemic conditions as below:

  • Currently or potentially using any drug that will cause ocular toxicity, such as psoralen, risedronic acid; or tamoxifen etc.
  • Allergic to sodium fluorescein, indocyanine green, therapeutic or diagnostic protein products, and allergic to ≥ two drugs or non-drugs, or with current allergic disease
  • Uncontrolled diabetes mellitus (fast glucose level ≥7.0 mmol/L or ≥11.1 mmol/L 2h after meal)
  • History of surgery and/or unhealed wound, ulcer, fracture etc. 1 month prior to screening
  • Any infectious disease requiring oral, intramuscular or intravenous administrations
  • History of Myocardial infarction and cerebral infarction within 6 months of screening
  • Active diffuse intravascular coagulation 3 months prior to screening
  • Systemic immunological diseases
  • Uncontrolled hypertension ≥150 mmHg systolic or ≥95 mmHg diastolic at baseline
  • Any severe or uncontrolled medical conditions (eg, unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renal disease or cancer or dementia)

Any abnormal laboratory results as below:

  • Abnormal liver or kidney function test value (glutamic-oxalacetic transaminase(AST), glutamic-pyruvic transaminase(ALT), creatinine(Crea), blood urea nitrogen(BUN) that was more than 1.2 times of the upper limit of normal value)
  • Abnormal coagulation test(≥3 sec of upper limit value of prothrombin time, ≥10 sec of upper limit value of activated partial thromboplastin time(APTT))
  • Positive in HbsAg, hepatitis C virus(HCV) antibody, human immunodeficiency virus(HIV) antibody and syphilis antibody

Other conditions related to subjects with women of childbearing potential:

  • Without using any contraceptive method
  • Pregnancy or lactation (urine pregnancy test positive)

Others:

  • Participated clinical studies using any medications (not including vitamins and minerals) 6 months prior to screening
  • Any assessment by the investigator to be unable to or unwilling to comply with requirements of the protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387566


Locations
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China, Shanghai
Shanghai General Hospital
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Huabo Biopharm Co., Ltd.
More Information
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Responsible Party: Huabo Biopharm Co., Ltd.
ClinicalTrials.gov Identifier: NCT03387566    
Other Study ID Numbers: HB002.1M-01
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Immunoglobulins
Endothelial Growth Factors
Immunologic Factors
Physiological Effects of Drugs
Growth Substances