Last updated on April 2019

Evaluating of the Safety Pharmacokinetics and Pharmacodynamics of QL1205 and Lucentis in Patients With Wet AMD


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03312283

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Recruitment Status: Closed


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