TAB014(Drug Code) in Wet( Neovascular)Age-related Macular Degeneration(AMD) Subjects

September 24, 2018 updated by: Lee's Pharmaceutical Limited

A Phase Ⅰ Clinical Study of TAB014 in Wet( Neovascular)Age-related Macular Degeneration(AMD) Subjects

Subjects with secondary wet age-related macular degeneration(AMD) or recurrent subfoveal choroidal neovascularization (CNV) in only one study eye will be enrolled into the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The screening period was 28 days. The classification of CNV will be determined by Fundus Fluorescein Angiography ( FFA ) at the study centers. Subjects will receive intravitreal injections of TAB014 Monoclonal Antibody Injection in one eye ( the study eye ). Subjects will only receive single intravitreal dose.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • 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 Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
        • Contact:
        • 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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects, 50 years of age or older.
  2. Have secondary actively Age-related macular degeneration(wAMD) or recurrent CNV including subfoveal type and extrafoveal type in the only study eye.
  3. If have occult CNV or partial classic CNV lesions will be enrolled into the study.
  4. The total CNV area(both classic and occult lesion) including lesion area are more than or equal to 50% total lesion areas.
  5. The total lesion area is less than or equal to 12 disk area (DA).
  6. Volunteer to participate in the study and able to read and understand informed consent and provide written informed consent.

Exclusion Criteria:

1. Prior and concomitant therapy

  1. Prior use of verteporfin, external beam radiation therapy or transpupillary thermotherapy(TTT) in 6 months period of the screening.
  2. Subjects that have received angiogenesis inhibitors therapy, such as Pegaptanib Sodium, Lucentis, Bevacizumab, Bevacizumab (RETAANE) or protein kinase C inhibitor in either eye are participating in any other research study within the last 6 months before the screening.
  3. Subjects that have received other intravitreal injection therapy(Corticosteroids or device implants) in the study eye within the last 6 months before the screening.
  4. Subjects that have treated with focal argon laser photocoagulation for macular edema in study eye within the last 6 months before the screening.
  5. Subjects that have undergone previous photocoagulation of the retina(extrafoveal areas) in the study eye within the last 3 months before the screening.
  6. Subjects with a history of vitreoretinal surgery in the study eye.
  7. Subjects that have undergone previous AMD surgery or other surgical interventions.
  8. Subjects that have participated in other study of treatment with study drug(except for vitamins and minerals) within the last 3 months before the screening.

2. lesion features:

  1. Area of bleeding under the retina 50% total lesion areas or 4 disk area.
  2. Subfoveal fibrosis.
  3. CNV that be caused by the oter reasons in either eye,such as ocular histoplasmosis syndrome, craniocerebral trauma or pathological myopia.
  4. retinal pigment epithelium (RPE) tears. 3. concomitant eye disease:

1) Subjects with ongoing any concomitant eye disease(i.e cataracts or diabetic retinopathy) by the investigator's judgment:

  1. Vision loss caused by these diseases to cause interference with medical or operation intervention during 3 months study.

  2. Best corrected visual acuity (BCVA) loss at least of 2 lines Snellen equivalents (ETDRS 10 letters) at 3 months, if don't treat the disease.

    2) Subjects who are active endophthalmitis(with micro level or above). 3) Subjects with ongoing internal vitreous hemorrhage. 4) Subjects with Rhegmatogenous retinal detachment or history of macular holes stage 3/4.

    5) Subjects with history of idiopathic uveitis or autoimmune uveitis in either eye 6) Subjects with ongoing infectious conjunctivitis, infectious keratitis, infectious scleral or endophthalmitis in either eye.

    7) Subjects that have undergone previous intraocular surgery (including cataract surgery ) within the last 3 months before the screening.

    8) Subjects who are uncontrolled glaucoma(defined as intraocular pressure [IOP] 30 mmHg, even when treated with anti-glaucoma drugs).

    9) Subjects with history of glaucoma filtration surgery. 4. concomitant system disease:

    1. Subjects of child bearing ages will undergo pregnancy testing.
    2. Subjects with ongoing severe hepatic and renal disease or abnormal liver and kidney function(ALT, Angiotensin sensitivity test (AST) ≥1.5 ULN, Cr, UREA>ULN) at Baseline.
    3. Patients with other disease history,such as uncontrolled diabetics or hypertension, periinfarction within the last 6 months,as well as not suitable for this study per the investigator's judgment.
    4. Subjects with ongoing systemic infection therapy. 5.other:
    1. Subjects with history of fluoresceins allergy.
    2. Not get enough quality of fundus photography and fluorescein angiography used by reading and analysing from the reading center.
    3. Unwilling and not be able to return for all study visits

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.25mg(0.05ml) single-dose
Eight subjects will be treated with TAB014 1.25mg(0.05ml) single-dose
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
  • TAB014 monoclonal antibody injection
Experimental: 2.00mg(0.08ml) single-dose
Eight subjects will be treated with TAB014 2.00mg(0.08ml) single-dose
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
  • TAB014 monoclonal antibody injection
Experimental: 2.50mg(0.10ml) single-dose
Eight subjects will be treated with TAB014 2.50mg(0.10ml) single-dose
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
  • TAB014 monoclonal antibody injection
Experimental: 1.25mg(0.05ml) multiple-dose
Eight subjects will be treated with TAB014 1.25mg(0.05ml) multiple-dose after 1.25mg(0.05ml) single-dose
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
  • TAB014 monoclonal antibody injection
Experimental: 2.00mg(0.08ml) multiple-dose
Eight subjects will be treated with TAB014 2.00mg(0.08ml) multiple-dose after 2.00mg(0.08ml) single-dose
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
  • TAB014 monoclonal antibody injection
Experimental: 2.50mg(0.10ml) multiple-dose
Eight subjects will be treated with TAB014 2.50mg(0.10ml) multiple-dose after 2.50mg(0.10ml) single-dose
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
  • TAB014 monoclonal antibody injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity associated with TAB014 treatment (possibly, probably, or definitively) occurs within 28 days after a single dose of TAB014.
Time Frame: Within 12 weeks after administration
Describe the impairment of vision by examination.
Within 12 weeks after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity and adverse reaction
Time Frame: Within 12 weeks after administration
To Assess the dose-limiting toxicity and adverse reaction of TAB014 Monoclonal Antibody Injection.
Within 12 weeks after administration

Collaborators and Investigators

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

Sponsor

Lee's Pharmaceutical Limited

Investigators

  • Study Director: youxin chen, PHD, Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 15, 2018

Primary Completion (Anticipated)

February 15, 2019

Study Completion (Anticipated)

April 30, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZK-TAB-201709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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