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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.
Full description
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.
Enrollment
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Inclusion criteria
Note: If the subject's eyes both meet the inclusion criteria, the investigator will determines the target eye from a medical point of view.
Exclusion criteria
Patients with any of the following eye conditions:
Primary purpose
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48 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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