This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics, pharmacodynamics and efficacy of CMAB818 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 sites. Subjects will be sequentially enrolled according to the protocol in one of two cohorts and receive a single 0.5mg of CMAB818 or Lucentis® through intravitreal injection. The primary objective is to assess the initial clinical safety of intravitreal injection of CMAB818 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD). The secondary objective are to assess immnogenicity, pharmacokinetic, pharmacodynamics and the initial clinical efficacy of intravitreal injection of CMAB818 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Peking University People'S Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Number of Participants With Adverse Events That Are Related to Treatment
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant graded according to the common terminology criteria for adverse events (CTCAE) v.5.0 criteria, including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs
Time frame: 0~42 days
Number of Participants With anti-drug antibody
Blood samples were collected at the following time point: pre-dose, D14, D28, and D42
Time frame: 0~42 days
Percentage of neutralizing antibody
Subjects with a positive antibody response to ranibizumab were determined to test neutralizing antibody
Time frame: 0~42 days
AUC(0-t)
Blood samples were collected to measure the area under the concentration time curve from time 0 to last time
Time frame: 0~42 days
Cmax
Blood samples were collected to measure maximum concentration
Time frame: 0~42 days
CL
Blood samples were collected to measure clearance rate
Time frame: 0~42 days
Half-life (t1/2)
Blood samples were collected to measure half-life time
Time frame: 0~42 days
Pharmacodynamics
The plasma VEGF concentration from baseline were measured
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Time frame: 0~42 days
Mean change in best corrected visual acuity (BCVA) from baseline
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visualacuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient
Time frame: 0~42 days
Mean change in central retinal thickness from baseline
Central retinal thickness was measured using the Optical Coherence Tomography
Time frame: 0~42 days
Mean change in lesion area from baseline
The lesion area was measured using Fundus Fluorescein Angiography
Time frame: 0~42 days
Mean change in leakage area from baseline
The leakage area was measured using Fundus Fluorescein Angiography
Time frame: 0~42 days