A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration

February 27, 2018 updated by: Jiangsu T-Mab Biopharma Co.,Ltd

A Multi-center, Open-label Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-Related Macular Degeneration

This is a multicenter, open-label study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients with AMD. It consists of core study (12 weeks) and extension study (40 weeks).

Study Overview

Status

Status

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

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.

Detailed Description

This is a multicenter, open-label study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients with AMD. It consists of core study (12 weeks) and extension study (40 weeks). In the core study, patients will receive their assigned dose in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose. The safety, pharmacokinetics, immunogenicity, and preliminary efficacy of TK001 will be evaluated in the core study, and will also be assessed in the extension study except pharmacokinetics.

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 (Anticipated)

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.
36

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Not yet recruiting
        • Chinese Academy of Medicine Sciences，Peking Union Medical College Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Province People's Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610047
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Not yet recruiting
        • The Eye Hospital of WMU(Zhejiang eye hospital)
        • Contact:

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

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent
  • Aged 45 - 80 years, male or female
  • Diagnosed with neovascular AMD and with active lesions
  • Best corrected VA for the studied eye≤20/40
  • With stable blood pressure, SBP<140 mmHg and DBP<90 mmHg

Exclusion Criteria:

Limitation of eye diseases

  • With vitreous hemorrhage in studied eyes within two months preceding screening
  • With geographic atrophy, epiretinal membrane or intensive subfoveal hard exudates which involved the foveal in studied eyes
  • With opacity of refractive media(e.g. apparent cataract) or contraction of pupils which significantly interfered the visual test or assessment of anterior segment and fundus in studied eyes
  • With pseudoexfoliation syndrome, intraocular hemorrhage resulting in decreased vision, rhegmatogenous retinal detachment, macular hole or choroidal neovascularization (CNV) for any reason except for AMD (such as fundus angioid streaks, ocular histoplasmosis, pathologic myopia, trauma) in studied eyes
  • With apparent afferent pupillary defect(APD) in studied eyes
  • With Polypoidal Choroidal Vasculopathy (PCV) or Retinal Angiomatous Proliferation (PAP) in studied eyes
  • With intraocular pressure higher than 25mmHg despite treatment
  • With VA for the fellow eyes<20/200
  • With active inflammation in any eye, such as conjunctivitis, keratitis, scleritis, blepharitis, endophthalmitis and uveitis The treatment of the eye
  • The studied eye received topical or grid photocoagulation more than twice or within 3 months preceding screening
  • The studied eye received the following intraocular surgery or laser treatment in macular (such as macular translocation surgery, glaucoma filtering surgery, transpupillary thermotherapy, macular photocoagulation, vitreous cutting surgery, optic nerve dissection, optic nerve sheath membrane dissection). But patients who received verteporfin photodynamic therapy, cataract surgery or YAG posterior capsular dissection more than 3 months before screening will not be excluded.
  • Any eye received antiangiogenic drugs within 2 months preceding screening or patients received systemic antiangiogenic drugs within 3 months preceding screening (such as pegaptanib, aflibercept, ranibizumab, bevacizumab or conbercept)
  • Any eye received intraocular injection of corticosteroid drugs (such as triamcinolone acetonide) within 3 months preceding screening, or periocular injection of corticosteroid drugs within 1 month before screening Systemic diseases, treatment and other conditions
  • With a history of allergy to sodium fluorescein and indocyanine green
  • PLT≤100×109/L, BUN or Cr>1.5×ULN(Upper Limit of Normal), TT(thrombin time) or PT(prothrombin time) >1.0×ULN(Upper Limit of Normal), take anti-platelet aggregation drugs or anticoagulants within 1 month before screening
  • With surgery within 1 month before screening, or with unhealed wound, ulcer, fracture at present
  • Diabetic patients without the control of glucose or accompanied by diabetic retinopathy
  • With a history of myocardial infarction within 6 months before screening
  • With activity disseminated intravascular coagulation and a tendency of significant bleeding before screening
  • Systemic autoimmune disease
  • Any uncontrolled diseases (such as severe systemic diseases of mental, neurological, cardiovascular, respiratory and malignancies)
  • Pregnant and lactating women or patients who cannot take contraceptive measures
  • Poor compliance
  • Patients who participated other clinical trials within 30 days before screening or was taking other clinical trials at present
  • Patients who is considered unsuitable for enrollment by investigator

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: PARALLEL
  • Masking: NONE

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: 0.5mg
In the core study, patients will receive 0.5mg TK001 in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose.
Biological: TK001
TK001 will be administered intravitreal injection.
Other Names:
  • anti-VEGF humanized monoclonal antibody injection
EXPERIMENTAL: 1.0mg
In the core study, patients will receive 1.0mg TK001 in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose.
Biological: TK001
TK001 will be administered intravitreal injection.
Other Names:
  • anti-VEGF humanized monoclonal antibody injection
EXPERIMENTAL: 1.5mg
In the core study, patients will receive 1.5mg TK001 in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose.
Biological: TK001
TK001 will be administered intravitreal injection.
Other Names:
  • anti-VEGF humanized monoclonal antibody 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
Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the first 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the following 40 weeks
Time Frame: 40 weeks
Extension Study
40 weeks

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
Area under the plasma concentration-time curve (AUC)
Time Frame: 12 weeks
Core Study
12 weeks
Maximum plasma concentration (Cmax)
Time Frame: 12 weeks
Core Study
12 weeks
Time to reach maximum concentration (Tmax)
Time Frame: 12 weeks
Core Study
12 weeks
Elimination half-Life (T½)
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the Best Corrected Visual Acuity at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the mean central retinal thickness at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the thickness of choroidal neovascularization at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in macular volume at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the area of choroidal neovascularization at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the area of leakage at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the total lesion size at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks
Time Frame: 12 weeks
Core Study
12 weeks
Change from baseline in the Best Corrected Visual Acuity at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Change from baseline in the mean central retinal thickness at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Change from baseline in the thickness of choroidal neovascularization at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Change from baseline in macular volume at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Change from baseline in the area of choroidal neovascularization at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Change from baseline in the area of leakage at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Change from baseline in the total lesion size at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks
Time Frame: 40 weeks
Extension Study
40 weeks

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.
Jiangsu T-Mab Biopharma 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.
October 18, 2017

Primary Completion (ANTICIPATED)

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.
November 1, 2018

Study Completion (ANTICIPATED)

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.
November 1, 2018

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).
January 12, 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.
January 12, 2017

First Posted (ESTIMATE)

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 16, 2017

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.
March 1, 2018

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.
February 27, 2018

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.
February 1, 2018

More Information

Terms related to this study

Keywords

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.
  • Tmab-TK001-AMD-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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