search
Back to results

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

Primary Purpose

Neovascular Age-Related Macular Degeneration

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TK001
Sponsored by
Jiangsu T-Mab Biopharma Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration focused on measuring Neovascular Age-Related Macular Degeneration, Anti-VEGF, CNV, TK001

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
  • PLT≤100×109/L, BUN or Cr>1.5×ULN(Upper Limit of Normal), TT(thrombin time) or PT(prothrombin time) >1.0×ULN(Upper Limit of Normal), take anti-platelet aggregation drugs or anticoagulants within 1 month before screening
  • With surgery within 1 month before screening, or with unhealed wound, ulcer, fracture at present
  • Diabetic patients without the control of glucose or accompanied by diabetic retinopathy
  • With a history of myocardial infarction within 6 months before screening
  • With activity disseminated intravascular coagulation and a tendency of significant bleeding before screening
  • Systemic autoimmune disease
  • Any uncontrolled diseases (such as severe systemic diseases of mental, neurological, cardiovascular, respiratory and malignancies)
  • Pregnant and lactating women or patients who cannot take contraceptive measures
  • Poor compliance
  • Patients who participated other clinical trials within 30 days before screening or was taking other clinical trials at present
  • Patients who is considered unsuitable for enrollment by investigator

Sites / Locations

  • Chinese Academy of Medicine Sciences，Peking Union Medical College Hospital
  • Henan Province People's Hospital
  • ShangHai General Hospital
  • West China Hospital, Sichuan UniversityRecruiting
  • The Eye Hospital of WMU(Zhejiang eye hospital)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

0.5mg

1.0mg

1.5mg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Area under the plasma concentration-time curve (AUC)
Core Study
Maximum plasma concentration (Cmax)
Core Study
Time to reach maximum concentration (Tmax)
Core Study
Elimination half-Life (T½)
Core Study
Change from baseline in the Best Corrected Visual Acuity at 12 weeks
Core Study
Change from baseline in the mean central retinal thickness at 12 weeks
Core Study
Change from baseline in the thickness of choroidal neovascularization at 12 weeks
Core Study
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks
Core Study
Change from baseline in macular volume at 12 weeks
Core Study
Change from baseline in the area of choroidal neovascularization at 12 weeks
Core Study
Change from baseline in the area of leakage at 12 weeks
Core Study
Change from baseline in the total lesion size at 12 weeks
Core Study
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks
Core Study
Change from baseline in the Best Corrected Visual Acuity at 52 weeks
Extension Study
Change from baseline in the mean central retinal thickness at 52 weeks
Extension Study
Change from baseline in the thickness of choroidal neovascularization at 52 weeks
Extension Study
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks
Extension Study
Change from baseline in macular volume at 52 weeks
Extension Study
Change from baseline in the area of choroidal neovascularization at 52 weeks
Extension Study
Change from baseline in the area of leakage at 52 weeks
Extension Study
Change from baseline in the total lesion size at 52 weeks
Extension Study
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks
Extension Study

Full Information

First Posted
January 12, 2017
Last Updated
February 27, 2018
Sponsor
Jiangsu T-Mab Biopharma Co.,Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03021785
Brief Title
A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration
Official Title
A Multi-center, Open-label Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu T-Mab Biopharma Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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). In the core study, patients will receive their assigned dose 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. The safety, pharmacokinetics, immunogenicity, and preliminary efficacy of TK001 will be evaluated in the core study, and will also be assessed in the extension study except pharmacokinetics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration
Keywords
Neovascular Age-Related Macular Degeneration, Anti-VEGF, CNV, TK001

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.5mg
Arm Type
Experimental
Arm Description
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.
Arm Title
1.0mg
Arm Type
Experimental
Arm Description
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.
Arm Title
1.5mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
TK001
Other Intervention Name(s)
anti-VEGF humanized monoclonal antibody injection
Intervention Description
TK001 will be administered intravitreal injection.
Primary Outcome Measure Information:
Title
Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the first 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the following 40 weeks
Description
Extension Study
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Area under the plasma concentration-time curve (AUC)
Description
Core Study
Time Frame
12 weeks
Title
Maximum plasma concentration (Cmax)
Description
Core Study
Time Frame
12 weeks
Title
Time to reach maximum concentration (Tmax)
Description
Core Study
Time Frame
12 weeks
Title
Elimination half-Life (T½)
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the Best Corrected Visual Acuity at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the mean central retinal thickness at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the thickness of choroidal neovascularization at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in macular volume at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the area of choroidal neovascularization at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the area of leakage at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the total lesion size at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks
Description
Core Study
Time Frame
12 weeks
Title
Change from baseline in the Best Corrected Visual Acuity at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Change from baseline in the mean central retinal thickness at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Change from baseline in the thickness of choroidal neovascularization at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Change from baseline in macular volume at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Change from baseline in the area of choroidal neovascularization at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Change from baseline in the area of leakage at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Change from baseline in the total lesion size at 52 weeks
Description
Extension Study
Time Frame
40 weeks
Title
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks
Description
Extension Study
Time Frame
40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 PLT≤100×109/L, BUN or Cr>1.5×ULN(Upper Limit of Normal), TT(thrombin time) or PT(prothrombin time) >1.0×ULN(Upper Limit of Normal), take anti-platelet aggregation drugs or anticoagulants within 1 month before screening With surgery within 1 month before screening, or with unhealed wound, ulcer, fracture at present Diabetic patients without the control of glucose or accompanied by diabetic retinopathy With a history of myocardial infarction within 6 months before screening With activity disseminated intravascular coagulation and a tendency of significant bleeding before screening Systemic autoimmune disease Any uncontrolled diseases (such as severe systemic diseases of mental, neurological, cardiovascular, respiratory and malignancies) Pregnant and lactating women or patients who cannot take contraceptive measures Poor compliance Patients who participated other clinical trials within 30 days before screening or was taking other clinical trials at present Patients who is considered unsuitable for enrollment by investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongwei Miao
Phone
+86(21)61160520
Email
miaohongwei@sh-qingfeng.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Zhang
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medicine Sciences，Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YouXin Chen
Phone
+86 138-0102-5971
Email
chenyouxinpumch@163.com
Facility Name
Henan Province People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZongMing Song
Phone
+86 188-0371-8289
Email
szmeyes@126.com
Facility Name
ShangHai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SuQing Yu
Phone
+86 137-0173-9566
Email
sq-yu@163.com
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610047
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Zhang
Phone
+86 189-8060-2122
Email
zhangmingscu@163.com
Facility Name
The Eye Hospital of WMU(Zhejiang eye hospital)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XiaoLing Liu
Phone
+86 137-5871-1161
Email
drliuxiaolin@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs