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

July 28, 2020 updated by: Huabo Biopharm Co., Ltd.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Up to 1 month after the single dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
T1/2 (Terminal phase half life) after single dose
Time Frame: 1 months
1 months
Cmax (maximum observed concentration) after single dose
Time Frame: 1 months
1 months
AUC (Area Under Concentration-Time Curve) after single dose
Time Frame: 1 months
1 months
Immunogenicity Evaluation after single dose
Time Frame: 2 months
Incidence of ADA(Anti-Drug Antibody) response
2 months
Change in Best Corrected Visual Acuity (BCVA) from baseline
Time Frame: 1 month
1 month
Change in central retinal thickness from baseline by Optical Coherence Tomography (OCT)
Time Frame: 1 month
1 month
Change in Choroidal Neovascularization (CNV) lesion area from baseline according to fluorescein angiogram
Time Frame: 1 month
1 month
Change of VEGF(Vascular Endothelial Growth Factor A) from baseline
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huabo Biopharm Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HB002.1M-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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