An interventional study of Experimental in Macular Degeneration, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Other
Phase I clinical trial on safety, tolerance, pharmacokinetics (PK) and pharmacodynamics of recombinant human anti-VEGF monoclonal antibody injection in patients with neovascular (wet) age-related macular degeneration
Test drug:Recombinant humanized anti VEGF monoclonal antibody injection; Research Phase:Phase I; Subjects:Subjects with neovascular (wet) age-related macular degeneration; Number of Subjects:24; Trial design:Single center, non randomized, open, single arm, single dose, dose escalation; Research objective:to rearch the safety and tolerance of JY028 injection;to rearch PK of JY028 injection;to observe the efficacy of JY028 in the treatment of nAMD;to rearch the relationship between plasma VEGF concentration and JY028 concentration. to rearch immunogenicity of JY028;
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 24 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
Drug: Experimental
Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
Also known as: intravitreous injection
JY028 related incidence of ocular and systemic adverse events and serious adverse events
JY028 related incidence of ocular and systemic adverse events and serious adverse events
Time frame: 13 weeks
Cmax
Maximum blood drug concentration
Time frame: 13 weeks
Tmax
Peak time of blood drug concentration
Time frame: 13 weeks
BCVA
The best corrected visual acuity change
Time frame: 13 weeks
AUC0-t、AUCinf
The area under the plasma concentration time curves
Time frame: 13 weeks
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Beijing Tongren Hospital