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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675880
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
AMD Drug: TAB014 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅰ Clinical Study of TAB014 in Wet( Neovascular)Age-related Macular Degeneration(AMD) Subjects
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: TAB014 monoclonal antibody injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03675880


Contacts
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Contact: youxin chen, PHD 010-69156699 chenyouxinpumch@163.com
Contact: yan sun, master 010-69158355 xieheyaoli@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100032
Contact: youxin chen, PHD    010-69156699    chenyouxinpumch@163.com   
Contact: yan sun, master    010-69158355    xieheyaoli@163.com   
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
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Study Director: youxin chen, PHD Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Publications of Results:

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03675880    
Other Study ID Numbers: ZK-TAB-201709
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs