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AMDPhase 1NCT03675880

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

A Phase 1 study testing TAB014 in people with AMD, run by Lee's Pharmaceutical Limited at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
AMD
What is being tested?
TAB014
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
15 Jun 2018to 30 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1. 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.
Show all 30Show fewer
  • 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.
  • 2. 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:
  • 1) Subjects with ongoing any concomitant eye disease(i.e cataracts or diabetic retinopathy) by the investigator's judgment:
  • Vision loss caused by these diseases to cause interference with medical or operation intervention during 3 months study.
  • 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:
  • Subjects of child bearing ages will undergo pregnancy testing.
  • 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.
  • 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.
  • Subjects with ongoing systemic infection therapy. 5.other:
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  • Subjects with history of fluoresceins allergy.
  • Not get enough quality of fundus photography and fluorescein angiography used by reading and analysing from the reading center.
  • Unwilling and not be able to return for all study visits

Trial locations and contacts

1 site in 1 country.

youxin chen, PHD contact

010-69156699

chenyouxinpumch@163.com

yan sun, master contact

010-69158355

xieheyaoli@163.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100032

    youxin chen, PHD, 010-69156699, chenyouxinpumch@163.com

    yan sun, master, 010-69158355, xieheyaoli@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
AMD
Being tested
TAB014

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAB014Drug

    Also called TAB014 monoclonal antibody injection

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

Study groups in NCT03675880
Study groupRoleWhat they receive
1.25mg(0.05ml) single-doseExperimentalEight subjects will be treated with TAB014 1.25mg(0.05ml) single-dose
Receives: Drug: TAB014
2.00mg(0.08ml) single-doseExperimentalEight subjects will be treated with TAB014 2.00mg(0.08ml) single-dose
Receives: Drug: TAB014
2.50mg(0.10ml) single-doseExperimentalEight subjects will be treated with TAB014 2.50mg(0.10ml) single-dose
Receives: Drug: TAB014
1.25mg(0.05ml) multiple-doseExperimentalEight subjects will be treated with TAB014 1.25mg(0.05ml) multiple-dose after 1.25mg(0.05ml) single-dose
Receives: Drug: TAB014
2.00mg(0.08ml) multiple-doseExperimentalEight subjects will be treated with TAB014 2.00mg(0.08ml) multiple-dose after 2.00mg(0.08ml) single-dose
Receives: Drug: TAB014
2.50mg(0.10ml) multiple-doseExperimentalEight subjects will be treated with TAB014 2.50mg(0.10ml) multiple-dose after 2.50mg(0.10ml) single-dose
Receives: Drug: TAB014

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 12 weeks after administration

Secondary outcomes (1)

  1. Dose-limiting toxicity and adverse reaction

    To Assess the dose-limiting toxicity and adverse reaction of TAB014 Monoclonal Antibody Injection.

    Measured: Within 12 weeks after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2018
  2. Study start15 Jun 2018
  3. Primary completion15 Feb 2019 (estimated)
  4. Study completion30 Apr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03675880
Sponsor's protocol ID
ZK-TAB-201709
Status last verified
Sep 2018
First submitted
5 Sep 2018
Last updated
26 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18843500

  • 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.

    PubMed 19680279

  • 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.

    PubMed 21623685

  • 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.

    PubMed 23638418

  • 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.

    PubMed 25142373

  • 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.

    PubMed 16508423

  • 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.

    PubMed 17031287

  • 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.

    PubMed 16508424

  • 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.

    PubMed 17698196

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAB014 in people with AMD, run by Lee's Pharmaceutical Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact youxin chen, PHD (010-69156699, chenyouxinpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03675880, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.

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