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

NCT03675880 | Unknown Phase 1 DMC

• 1 other identifier: ZK-TAB-201709
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

• Toxicity associated with TAB014 treatment (possibly, probably, or definitively) occurs within 28 days after a single dose of TAB014.

  Describe the impairment of vision by examination.

  Within 12 weeks after administration

Secondary Outcomes (1)

• Dose-limiting toxicity and adverse reaction

  Within 12 weeks after administration

Study Arms (6)

1.25mg(0.05ml) single-dose

EXPERIMENTAL

Eight subjects will be treated with TAB014 1.25mg(0.05ml) single-dose

Drug: TAB014

2.00mg(0.08ml) single-dose

EXPERIMENTAL

Eight subjects will be treated with TAB014 2.00mg(0.08ml) single-dose

Drug: TAB014

2.50mg(0.10ml) single-dose

EXPERIMENTAL

Eight subjects will be treated with TAB014 2.50mg(0.10ml) single-dose

Drug: TAB014

1.25mg(0.05ml) multiple-dose

EXPERIMENTAL

Eight subjects will be treated with TAB014 1.25mg(0.05ml) multiple-dose after 1.25mg(0.05ml) single-dose

Drug: TAB014

2.00mg(0.08ml) multiple-dose

EXPERIMENTAL

Eight subjects will be treated with TAB014 2.00mg(0.08ml) multiple-dose after 2.00mg(0.08ml) single-dose

Drug: TAB014

2.50mg(0.10ml) multiple-dose

EXPERIMENTAL

Eight subjects will be treated with TAB014 2.50mg(0.10ml) multiple-dose after 2.50mg(0.10ml) single-dose

Drug: TAB014

Interventions

TAB014 DRUG

TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)

Also known as: TAB014 monoclonal antibody injection

1.25mg(0.05ml) multiple-dose; 1.25mg(0.05ml) single-dose; 2.00mg(0.08ml) multiple-dose; 2.00mg(0.08ml) single-dose; 2.50mg(0.10ml) multiple-dose; 2.50mg(0.10ml) single-dose

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Prior and concomitant therapy
• Prior use of verteporfin, external beam radiation therapy or transpupillary thermotherapy(TTT) in 6 months period of the screening.
• 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.
• Subjects that have received other intravitreal injection therapy(Corticosteroids or device implants) in the study eye within the last 6 months before the screening.
• Subjects that have treated with focal argon laser photocoagulation for macular edema in study eye within the last 6 months before the screening.
• Subjects that have undergone previous photocoagulation of the retina(extrafoveal areas) in the study eye within the last 3 months before the screening.
• Subjects with a history of vitreoretinal surgery in the study eye.
• Subjects that have undergone previous AMD surgery or other surgical interventions.
• 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.
• \. lesion features:
• Area of bleeding under the retina 50% total lesion areas or 4 disk area.
• Subfoveal fibrosis.
• CNV that be caused by the oter reasons in either eye,such as ocular histoplasmosis syndrome, craniocerebral trauma or pathological myopia.
• retinal pigment epithelium (RPE) tears. 3. concomitant eye disease:
• \) Subjects with ongoing any concomitant eye disease(i.e cataracts or diabetic retinopathy) by the investigator's judgment:

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100032, China

RECRUITING

Related Publications (9)

• Schouten JS, La Heij EC, Webers CA, Lundqvist IJ, Hendrikse F. A systematic review on the effect of bevacizumab in exudative age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2009 Jan;247(1):1-11. doi: 10.1007/s00417-008-0952-y. Epub 2008 Oct 9.

  PMID: 18843500 RESULT

• Jyothi S, Chowdhury H, Elagouz M, Sivaprasad S. Intravitreal bevacizumab (Avastin) for age-related macular degeneration: a critical analysis of literature. Eye (Lond). 2010 May;24(5):816-24. doi: 10.1038/eye.2009.219. Epub 2009 Aug 14.

  PMID: 19680279 RESULT

• Mitchell P. A systematic review of the efficacy and safety outcomes of anti-VEGF agents used for treating neovascular age-related macular degeneration: comparison of ranibizumab and bevacizumab. Curr Med Res Opin. 2011 Jul;27(7):1465-75. doi: 10.1185/03007995.2011.585394. Epub 2011 May 31.

  PMID: 21623685 RESULT

• Li J, Zhang H, Sun P, Gu F, Liu ZL. Bevacizumab vs ranibizumab for neovascular age-related macular degeneration in Chinese patients. Int J Ophthalmol. 2013 Apr 18;6(2):169-73. doi: 10.3980/j.issn.2222-3959.2013.02.12. Print 2013.

  PMID: 23638418 RESULT

• Kodjikian L, Decullier E, Souied EH, Girmens JF, Durand EE, Chapuis FR, Huot L. Bevacizumab and ranibizumab for neovascular age-related macular degeneration: an updated meta-analysis of randomised clinical trials. Graefes Arch Clin Exp Ophthalmol. 2014 Oct;252(10):1529-37. doi: 10.1007/s00417-014-2764-6. Epub 2014 Aug 22.

  PMID: 25142373 RESULT

• Manzano RP, Peyman GA, Khan P, Kivilcim M. Testing intravitreal toxicity of bevacizumab (Avastin). Retina. 2006 Mar;26(3):257-61. doi: 10.1097/00006982-200603000-00001.

  PMID: 16508423 RESULT

• Feiner L, Barr EE, Shui YB, Holekamp NM, Brantley MA Jr. Safety of intravitreal injection of bevacizumab in rabbit eyes. Retina. 2006 Oct;26(8):882-8. doi: 10.1097/01.iae.0000230717.85319.f5.

  PMID: 17031287 RESULT

• Shahar J, Avery RL, Heilweil G, Barak A, Zemel E, Lewis GP, Johnson PT, Fisher SK, Perlman I, Loewenstein A. Electrophysiologic and retinal penetration studies following intravitreal injection of bevacizumab (Avastin). Retina. 2006 Mar;26(3):262-9. doi: 10.1097/00006982-200603000-00002.

  PMID: 16508424 RESULT

• Diabetic Retinopathy Clinical Research Network; Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, Elman MJ, Friedman SM, Greven CM, Maturi RK, Pieramici DJ, Shami M, Singerman LJ, Stockdale CR. A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology. 2007 Oct;114(10):1860-7. doi: 10.1016/j.ophtha.2007.05.062. Epub 2007 Aug 15.

  PMID: 17698196 RESULT

Study Officials

• youxin chen, PHD

  Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

youxin chen, PHD

CONTACT

010-69156699; chenyouxinpumch@163.com

yan sun, master

CONTACT

010-69158355; xieheyaoli@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 18, 2018
• Study Start: June 15, 2018
• Primary Completion: February 15, 2019
• Study Completion: April 30, 2019
• Last Updated: September 26, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)