Wet Age-related Macular Degeneration Clinical Trial
Official title:
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 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.
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