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

NCT03021785 | Unknown Phase 1

• 1 other identifier: Tmab-TK001-AMD-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration; Anti-VEGF; CNV; TK001

Outcome Measures

Primary Outcomes (2)

• Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the first 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

  Extension Study

  40 weeks

Secondary Outcomes (22)

• Area under the plasma concentration-time curve (AUC)

  12 weeks

• Maximum plasma concentration (Cmax)

  12 weeks

• Time to reach maximum concentration (Tmax)

  12 weeks

• Elimination half-Life (T½)

  12 weeks

• Change from baseline in the Best Corrected Visual Acuity at 12 weeks

  12 weeks

Study Arms (3)

0.5mg

EXPERIMENTAL

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

1.0mg

EXPERIMENTAL

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

1.5mg

EXPERIMENTAL

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

Interventions

TK001 BIOLOGICAL

TK001 will be administered intravitreal injection.

Also known as: anti-VEGF humanized monoclonal antibody injection

0.5mg; 1.0mg; 1.5mg

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu T-Mab Biopharma Co.,Ltd: lead

Study Sites (5)

Chinese Academy of Medicine Sciences，Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

NOT YET RECRUITING

Henan Province People's Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

ShangHai General Hospital

Shanghai, Shanghai Municipality, 200080, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610047, China

RECRUITING

The Eye Hospital of WMU(Zhejiang eye hospital)

Wenzhou, Zhejiang, 325027, China

NOT YET RECRUITING

Study Officials

• Ming Zhang

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongwei Miao

CONTACT

+86(21)61160520; miaohongwei@sh-qingfeng.net

Study Design

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

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 16, 2017
• Study Start: October 18, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

CN (5)