This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics and pharmacodynamics of QL1205 and Lucentis® in patients with wet age-related macular degeneration.
This is a phase I, randomized, double-blind, two-group parallel, positive-controlled clinical trial at four centers. The primary objective is to assess the initial clinical safety of intravitreal injection of QL1205 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD). The secondary objective are to assess the initial clinical effectiveness and pharmacokinetic characteristics of intravitreal injection of QL1205 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD). Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 0.5mg of QL1205 or Lucentis® once a month for three months through vitreous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
To evaluate the safety of QL1205
To evaluate the safety of QL1205, compared to that of Lucentis (registered trademark) in patients with neovascular AMD.This will be done by assessment of vital signs, physical examination, laboratory blood tests and adverse events.
Time frame: 85 days
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