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

Jiangsu T-Mab Biopharma Co.,Ltd5 sites in 1 country36 target enrollmentOctober 18, 2017

ConditionsNeovascular Age-Related Macular Degeneration

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Neovascular Age-Related Macular Degeneration
Sponsor: Jiangsu T-Mab Biopharma Co.,Ltd
Enrollment: 36
Locations: 5
Primary Endpoint: Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the first 12 weeks
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 18, 2017

End Date

November 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu T-Mab Biopharma Co.,Ltd

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Maximum plasma concentration (Cmax)(12 weeks)
Elimination half-Life (T½)(12 weeks)
Change from baseline in the Best Corrected Visual Acuity at 12 weeks(12 weeks)
Time to reach maximum concentration (Tmax)(12 weeks)
Change from baseline in the thickness of choroidal neovascularization at 12 weeks(12 weeks)
Change from baseline in the mean central retinal thickness at 12 weeks(12 weeks)
Change from baseline in the area of leakage at 12 weeks(12 weeks)
Change from baseline in the total lesion size at 12 weeks(12 weeks)
Change from baseline in macular volume at 52 weeks(40 weeks)
Change from baseline in the area of leakage at 52 weeks(40 weeks)
Change from baseline in the total lesion size at 52 weeks(40 weeks)
Change from baseline in the area of choroidal neovascularization at 12 weeks(12 weeks)
Area under the plasma concentration-time curve (AUC)(12 weeks)
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks(12 weeks)
Change from baseline in macular volume at 12 weeks(12 weeks)
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks(40 weeks)
Change from baseline in the area of choroidal neovascularization at 52 weeks(40 weeks)
Change from baseline in the Best Corrected Visual Acuity at 52 weeks(40 weeks)
Change from baseline in the mean central retinal thickness at 52 weeks(40 weeks)
Change from baseline in the thickness of choroidal neovascularization at 52 weeks(40 weeks)
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks(12 weeks)
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks(40 weeks)