Neovascular Age-Related Macular DegenerationPhase 1NCT03021785
A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration
A Phase 1 study testing TK001 in people with Neovascular Age-Related Macular Degeneration, run by Jiangsu T-Mab Biopharma Co.,Ltd at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- TK001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesChina
- Study dates
- 18 Oct 2017to Nov 2018
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Chinese Academy of Medicine Sciences，Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
YouXin Chen, +86 138-0102-5971, chenyouxinpumch@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610047
Ming Zhang, +86 189-8060-2122, zhangmingscu@163.com
- Not yet recruiting
ShangHai General Hospital
Shanghai, Shanghai Municipality, 200080
SuQing Yu, +86 137-0173-9566, sq-yu@163.com
- Not yet recruiting
The Eye Hospital of WMU(Zhejiang eye hospital)
Wenzhou, Zhejiang, 325027
XiaoLing Liu, +86 137-5871-1161, drliuxiaolin@163.com
- Not yet recruiting
Henan Province People's Hospital
Zhengzhou, Henan, 450003
ZongMing Song, +86 188-0371-8289, szmeyes@126.com
About this study
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
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).
Read the 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.
- Being tested
- TK001
- Keywords
- Neovascular Age-Related Macular Degeneration, Anti-VEGF, CNV, TK001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TK001Biological
Also called anti-VEGF humanized monoclonal antibody injection
TK001 will be administered intravitreal injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: TK001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 40 weeks
Secondary outcomes (22)
Area under the plasma concentration-time curve (AUC)
Core Study
Measured: 12 weeks
Maximum plasma concentration (Cmax)
Core Study
Measured: 12 weeks
Time to reach maximum concentration (Tmax)
Core Study
Measured: 12 weeks
Elimination half-Life (T½)
Core Study
Measured: 12 weeks
Change from baseline in the Best Corrected Visual Acuity at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in the mean central retinal thickness at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in the thickness of choroidal neovascularization at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in macular volume at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in the area of choroidal neovascularization at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in the area of leakage at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in the total lesion size at 12 weeks
Core Study
Measured: 12 weeks
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks
Core Study
Measured: 12 weeks
Change from baseline in the Best Corrected Visual Acuity at 52 weeks
Extension Study
Measured: 40 weeks
Change from baseline in the mean central retinal thickness at 52 weeks
Extension Study
Measured: 40 weeks
Change from baseline in the thickness of choroidal neovascularization at 52 weeks
Extension Study
Measured: 40 weeks
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks
Extension Study
Measured: 40 weeks
Change from baseline in macular volume at 52 weeks
Extension Study
Measured: 40 weeks
Change from baseline in the area of choroidal neovascularization at 52 weeks
Extension Study
Measured: 40 weeks
Change from baseline in the area of leakage at 52 weeks
Extension Study
Measured: 40 weeks
Change from baseline in the total lesion size at 52 weeks
Extension Study
Measured: 40 weeks
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks
Extension Study
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start18 Oct 2017
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021785
- Sponsor's protocol ID
- Tmab-TK001-AMD-02
- Status last verified
- Feb 2018
- First submitted
- 12 Jan 2017
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03021785
- Acronym / sponsor ID
- Tmab-TK001-AMD-02
- Keywords
- Neovascular Age-Related Macular Degeneration, Anti-VEGF, CNV, TK001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.5mg | Experimental | Biological: TK001In 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. |
| 1.0mg | Experimental | Biological: TK001In 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. |
| 1.5mg | Experimental | Biological: TK001In 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TK001Also: anti-VEGF humanized monoclonal antibody injectionTK001 will be administered intravitreal injection. | Biological | 0.5mg, 1.0mg, 1.5mg |
Primary outcome
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
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
22 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: 12 weeks
Maximum plasma concentration (Cmax)
Time frame: 12 weeks
Time to reach maximum concentration (Tmax)
Time frame: 12 weeks
Elimination half-Life (T½)
Time frame: 12 weeks
Change from baseline in the Best Corrected Visual Acuity at 12 weeks
Time frame: 12 weeks
Change from baseline in the mean central retinal thickness at 12 weeks
Time frame: 12 weeks
Change from baseline in the thickness of choroidal neovascularization at 12 weeks
Time frame: 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
Change from baseline in macular volume at 12 weeks
Time frame: 12 weeks
Change from baseline in the area of choroidal neovascularization at 12 weeks
Time frame: 12 weeks
Change from baseline in the area of leakage at 12 weeks
Time frame: 12 weeks
Change from baseline in the total lesion size at 12 weeks
Time frame: 12 weeks
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks
Time frame: 12 weeks
Change from baseline in the Best Corrected Visual Acuity at 52 weeks
Time frame: 40 weeks
Change from baseline in the mean central retinal thickness at 52 weeks
Time frame: 40 weeks
Change from baseline in the thickness of choroidal neovascularization at 52 weeks
Time frame: 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
Change from baseline in macular volume at 52 weeks
Time frame: 40 weeks
Change from baseline in the area of choroidal neovascularization at 52 weeks
Time frame: 40 weeks
Change from baseline in the area of leakage at 52 weeks
Time frame: 40 weeks
Change from baseline in the total lesion size at 52 weeks
Time frame: 40 weeks
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks
Time frame: 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Zhang principal investigator
West China Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TK001 in people with Neovascular Age-Related Macular Degeneration, run by Jiangsu T-Mab Biopharma Co.,Ltd at 5 sites 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 5 inclusion and 26 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Hongwei Miao (+86(21)61160520, miaohongwei@sh-qingfeng.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2018.