- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03021785
A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration
February 27, 2018 updated by: Jiangsu T-Mab Biopharma Co.,Ltd
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
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100032
- Not yet recruiting
- Chinese Academy of Medicine Sciences,Peking Union Medical College Hospital
-
Contact:
- YouXin Chen
- Phone Number: +86 138-0102-5971
- Email: chenyouxinpumch@163.com
-
-
Henan
-
Zhengzhou, Henan, China, 450003
- Not yet recruiting
- Henan province people's hospital
-
Contact:
- ZongMing Song
- Phone Number: +86 188-0371-8289
- Email: szmeyes@126.com
-
-
Shanghai
-
Shanghai, Shanghai, China, 200080
- Not yet recruiting
- Shanghai General Hospital
-
Contact:
- SuQing Yu
- Phone Number: +86 137-0173-9566
- Email: sq-yu@163.com
-
-
Sichuan
-
Chengdu, Sichuan, China, 610047
- Recruiting
- West China Hospital, Sichuan University
-
Contact:
- Ming Zhang
- Phone Number: +86 189-8060-2122
- Email: zhangmingscu@163.com
-
-
Zhejiang
-
Wenzhou, Zhejiang, China, 325027
- Not yet recruiting
- The Eye Hospital of WMU(Zhejiang eye hospital)
-
Contact:
- XiaoLing Liu
- Phone Number: +86 137-5871-1161
- Email: drliuxiaolin@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 0.5mg
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.
|
TK001 will be administered intravitreal injection.
Other Names:
|
EXPERIMENTAL: 1.0mg
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.
|
TK001 will be administered intravitreal injection.
Other Names:
|
EXPERIMENTAL: 1.5mg
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.
|
TK001 will be administered intravitreal injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the first 12 weeks
Time Frame: 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
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration-time curve (AUC)
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Maximum plasma concentration (Cmax)
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Time to reach maximum concentration (Tmax)
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Elimination half-Life (T½)
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the Best Corrected Visual Acuity at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the mean central retinal thickness at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the thickness of choroidal neovascularization at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in macular volume at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the area of choroidal neovascularization at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the area of leakage at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the total lesion size at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks
Time Frame: 12 weeks
|
Core Study
|
12 weeks
|
Change from baseline in the Best Corrected Visual Acuity at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Change from baseline in the mean central retinal thickness at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Change from baseline in the thickness of choroidal neovascularization at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Change from baseline in macular volume at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Change from baseline in the area of choroidal neovascularization at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Change from baseline in the area of leakage at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Change from baseline in the total lesion size at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks
Time Frame: 40 weeks
|
Extension Study
|
40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 18, 2017
Primary Completion (ANTICIPATED)
November 1, 2018
Study Completion (ANTICIPATED)
November 1, 2018
Study Registration Dates
First Submitted
January 12, 2017
First Submitted That Met QC Criteria
January 12, 2017
First Posted (ESTIMATE)
January 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 1, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tmab-TK001-AMD-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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